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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
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Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
2
Product Code
EZX
Mesh, Surgical, Metal
2
Product Code
MIB
Elastomer, Silicone Block
2
Product Code
MIC
Implant, Muscle, Pectoralis
2
Product Code
BTX
Board, Arm (With Cover), Sterile
1
Product Code
FTL
Mesh, Surgical, Polymeric
2
Product Code
FTM
Mesh, Surgical
2
Product Code
K
23
3991
CanGaroo RM Antibacterial Envelope
2
Cleared 510(K)
K
24
1126
OviTex PRS
2
Cleared 510(K)
K
22
3052
Peri-Guard and Supple Peri-Guard
2
Cleared 510(K)
K
21
4070
OviTex PRS (Long Term Resorbable)
2
Cleared 510(K)
K
21
3163
VersaWrap
2
Cleared 510(K)
K
21
3125
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
2
Cleared 510(K)
K
20
3496
Nexo-Gide Bilayer Collagen Membrane
2
Cleared 510(K)
K
20
3600
VersaWrap
2
Cleared 510(K)
K
19
2452
Lyograft
2
Cleared 510(K)
K
20
1000
Biodesign Staple Line Reinforcement
2
Cleared 510(K)
K
20
1313
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
2
Cleared 510(K)
K
20
0311
VersaWrap Tendon Protector
2
Cleared 510(K)
K
19
2615
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
2
Cleared 510(K)
K
19
2616
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
2
Cleared 510(K)
K
18
2493
Bovine Pericardial Tissue Patch
2
Cleared 510(K)
K
18
3398
Endoform Restella
2
Cleared 510(K)
K
18
3472
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
2
Cleared 510(K)
K
18
2259
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
2
Cleared 510(K)
K
18
2255
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
2
Cleared 510(K)
K
17
1817
Biodesign Diaphragmatic Hernia Graft
2
Cleared 510(K)
K
17
3242
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
2
Cleared 510(K)
K
17
2937
Colorado Therapeutics Xenograft Implant
2
Cleared 510(K)
K
16
2934
Biodesign Parastomal Hernia Repair Graft
2
Cleared 510(K)
K
17
0016
Biodesign Fistula Plug
2
Cleared 510(K)
K
17
0763
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
2
Cleared 510(K)
K
16
2752
ARTIA Reconstructive Tissue Matrix Perforated
2
Cleared 510(K)
K
16
2965
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
2
Cleared 510(K)
K
16
2570
Miromatrix Biological Mesh TW
2
Cleared 510(K)
K
16
2388
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
2
Cleared 510(K)
K
16
2461
Endoform Plastics and Reconstructive Matrix
2
Cleared 510(K)
K
16
2554
Gentrix Surgical Matrix
2
Cleared 510(K)
K
16
0181
COLORADO THERAPEUTICS XENOGRAFT IMPLANT
2
Cleared 510(K)
K
16
1221
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
2
Cleared 510(K)
K
16
0869
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
2
Cleared 510(K)
K
15
3633
Endoform Reconstructive Template
2
Cleared 510(K)
K
15
2206
SurgiPure XD Reconstructive Tissue Matrix
2
Cleared 510(K)
K
15
0668
Biodesign Enterocutaneous Fistula Plug
2
Cleared 510(K)
K
14
2887
SIS Inguinal Hernia Repair Graft
2
Cleared 510(K)
K
15
0712
LTM-Perforated Surgical Mesh
2
Cleared 510(K)
K
14
1084
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
2
Cleared 510(K)
K
14
2326
HP Tissue Matrix
2
Cleared 510(K)
K
14
1721
BOVINE PERICARDIUM PATCH
2
Cleared 510(K)
K
14
1053
OVINE TISSUE MATRIX(OTM)
2
Cleared 510(K)
K
14
2070
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
2
Cleared 510(K)
K
14
0306
CORMATRIX PROTECT ECM ENVELOPE
2
Cleared 510(K)
K
13
3306
SIS HERNIA GRAFT
2
Cleared 510(K)
K
14
0501
XENMATRIX SURGICAL GRAFT
2
Cleared 510(K)
K
13
4033
MIROMATRIX BIOLOGICAL MESH
2
Cleared 510(K)
K
13
2025
MESO BILAYER SURGICAL MESH
2
Cleared 510(K)
K
13
0547
ENDOFORM RECONSTRUCTIVE TEMPLATE
2
Cleared 510(K)
K
12
3356
FORTIVA PORCINE DERMIS
2
Cleared 510(K)
K
12
2048
COLLAGEN TENDON SHEET-D
2
Cleared 510(K)
K
12
0605
PERMACOL SURGICAL IMPLANT
2
Cleared 510(K)
K
12
0019
COLLAGEN RIBBON
2
Cleared 510(K)
K
11
3460
SYNERGY TISSUE MATRIX
2
Cleared 510(K)
K
11
0581
PROPATCH SOFT TISSUE REPAIR MATRIX
2
Cleared 510(K)
K
11
2423
COLLAGEN TENDON SHEET
2
Cleared 510(K)
K
11
2786
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
2
Cleared 510(K)
K
11
1436
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
2
Cleared 510(K)
K
11
1584
XYLOS MACRO-POROUS SURGICAL MESH
2
Cleared 510(K)
K
11
0402
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
2
Cleared 510(K)
K
10
3787
MEDEOR MATRIX
2
Cleared 510(K)
K
10
1587
PROPATCH SOFT TISSUE REPAIR MATRIX
2
Cleared 510(K)
K
09
4061
KENSEY NASH ECM SURGICAL PATCH
2
Cleared 510(K)
K
09
1499
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
2
Cleared 510(K)
K
09
1142
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
2
Cleared 510(K)
K
09
0880
XYLOS POROUS SURGICAL MESH
2
Cleared 510(K)
K
09
0778
MTA PROTECTIVE SHEET
2
Cleared 510(K)
K
08
3823
SECURIAN TISSUE REINFORCEMENT MATRIX
2
Cleared 510(K)
K
08
2682
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
2
Cleared 510(K)
K
08
3898
SURGIMEND
2
Cleared 510(K)
K
08
3039
VERITAS COLLAGEN MATRIX (DRY)
2
Cleared 510(K)
K
08
2176
LTM-BPS SURGICAL MESH
2
Cleared 510(K)
K
08
2687
COLLAMEND FM IMPLANT
2
Cleared 510(K)
K
08
1272
PORCINE SURGICAL MESH; DERMAL MATRIX
2
Cleared 510(K)
K
08
1882
MODIFICATION TO XYLOS SURGICAL MESH
2
Cleared 510(K)
K
08
1538
TUTOPATCH, TUTOMESH
2
Cleared 510(K)
K
08
0452
COLLAGEN TENDON WRAP
2
Cleared 510(K)
K
07
3219
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
2
Cleared 510(K)
K
07
3391
SURGISIS BIODESIGN TISSUE GRAFT
2
Cleared 510(K)
K
07
1986
LTM-RC SURGICAL MESH
2
Cleared 510(K)
K
07
0405
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
2
Cleared 510(K)
K
07
1016
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
2
Cleared 510(K)
K
07
1807
ORTHOMEND SOFT TISSUE MATRIX
2
Cleared 510(K)
K
06
2558
MESOSFOL SURGICAL FILM
2
Cleared 510(K)
K
07
0560
LRTM SURGICAL MESH
2
Cleared 510(K)
K
07
1065
ORTHADAPT BIOIMPLANT
2
Cleared 510(K)
K
07
0738
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
2
Cleared 510(K)
K
06
3556
PERIPATCH ENDO-SLEEVE
2
Cleared 510(K)
K
06
2915
VERITAS COLLAGEN MATRIX
2
Cleared 510(K)
K
06
1892
PROPATCH SOFT TISSUE REPAIR MATRIX
2
Cleared 510(K)
K
06
3178
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
2
Cleared 510(K)
K
06
2696
SURGISIS, SURGISIS ES
2
Cleared 510(K)
K
06
2729
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
2
Cleared 510(K)
K
06
2320
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
2
Cleared 510(K)
K
05
3562
ZIMMER COLLAGEN REPAIR PATCH
2
Cleared 510(K)
K
06
0984
XENFORM SOFT TISSUE REPAIR MATRIX
2
Cleared 510(K)
K
06
0829
COSMATRIX
2
Cleared 510(K)
K
06
0989
TISSUEMEND SOFT TISSUE REPAIR MATRIX
2
Cleared 510(K)
K
06
1030
BIOBLANKET SURGICAL MESH
2
Cleared 510(K)
K
05
2322
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
2
Cleared 510(K)
K
05
3655
TENDON WRAP TENDON PROTECTOR
2
Cleared 510(K)
K
05
1879
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
2
Cleared 510(K)
K
05
1048
SURGISIS STAPLE LINE REINFORCEMENT II
2
Cleared 510(K)
K
04
3259
BIOBLANKET SURGICAL MESH
2
Cleared 510(K)
K
04
3388
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
2
Cleared 510(K)
K
05
0246
SIS DERMAL AUGMENTATION STRAND
2
Cleared 510(K)
K
05
0337
SIS FISTULA PLUG
2
Cleared 510(K)
K
04
2809
CUFFPATCH
2
Cleared 510(K)
K
04
1669
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
2
Cleared 510(K)
K
04
1923
BIOBLANKET
2
Cleared 510(K)
K
04
0756
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
2
Cleared 510(K)
K
04
1140
ACELL UBM SURGICAL MESH ML AND MLPLUS
2
Cleared 510(K)
K
04
0364
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
2
Cleared 510(K)
K
04
0835
PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
2
Cleared 510(K)
K
04
0868
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
2
Cleared 510(K)
K
03
3985
PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
2
Cleared 510(K)
K
04
0621
ACELL UBM SURGICAL MESH
2
Cleared 510(K)
K
04
0119
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
2
Cleared 510(K)
K
03
4039
SIS PLASTIC SURGERY MATRIX
2
Cleared 510(K)
K
03
1969
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
2
Cleared 510(K)
K
03
1332
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
2
Cleared 510(K)
K
03
0782
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
2
Cleared 510(K)
K
02
3237
XYLOS SURGICAL MESH
2
Cleared 510(K)
K
02
1056
PERMACOL
2
Cleared 510(K)
K
02
1160
DERMMATRIX SURGICAL MESH
2
Cleared 510(K)
K
02
1107
FORTAFLEX SURGICAL SLING
2
Cleared 510(K)
K
02
1105
FORTAFLEX SURGICAL MESH
2
Cleared 510(K)
K
02
0455
TISSUEMEND SOFT TISSUE REPAIR MATRIX
2
Cleared 510(K)
K
02
0049
FORTAFLEX SURGICAL MESH
2
Cleared 510(K)
K
01
3625
PERMACOL
2
Cleared 510(K)
K
01
1025
FORTAFLEX SURGICAL MESH
2
Cleared 510(K)
K
01
1027
FORTAFLEX SURGICAL SLING
2
Cleared 510(K)
K
00
1738
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
2
Cleared 510(K)
K
99
1296
TUTOPATCH
2
Cleared 510(K)
K
99
2537
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
2
Cleared 510(K)
K
99
1567
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
2
Cleared 510(K)
K
98
3162
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
2
Cleared 510(K)
K
98
2330
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
2
Cleared 510(K)
K
98
0431
SURGISIS
2
Cleared 510(K)
K
97
3379
STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
2
Cleared 510(K)
K
97
1048
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
2
Cleared 510(K)
K
96
3175
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
2
Cleared 510(K)
K
96
1810
SUPPLE PERI-GUARD PERICARDIUM
2
Cleared 510(K)
K
96
1811
PERI-GUARD PERICARDIUM
2
Cleared 510(K)
K
94
0205
PERI-STRIPS
2
Cleared 510(K)
K
92
2308
TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER
2
Cleared 510(K)
K
92
3657
SUPPLE PERI-GUARD
2
Cleared 510(K)
K
91
5774
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
2
Cleared 510(K)
K
89
6946
COATED NOVAFIL, POLYBUTESTER, MESH
2
Cleared 510(K)
K
89
4580
GORE-TEX SURGICAL TAPE
2
Cleared 510(K)
K
85
2011
NYLAMID MESH PAD FULL & HALF
2
Cleared 510(K)
K
85
1086
VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
2
Cleared 510(K)
K
84
4228
PDS POLYDIOXANONE MESH
2
Cleared 510(K)
K
84
4225
LINK ACETABULAR MESH
2
Cleared 510(K)
K
83
1725
FOIL IN 3 FORMS-NON-STERILE SHEETS
2
Cleared 510(K)
K
83
1727
QUARTER GLOBE CAPS
2
Cleared 510(K)
K
83
1723
SUPRAMID EXTRA SURGICAL MESH
2
Cleared 510(K)
K
83
1726
EYE MUSCLE SLEEVES
2
Cleared 510(K)
K
83
0889
DEXON 'S' POLYGLYCOLIC ACID MESH
2
Cleared 510(K)
K
82
0619
MECRON(R) ACETABULAR NETS TM
2
Cleared 510(K)
FTN
Plastic Surgery And Accessories Kit
1
Product Code
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
3
Product Code
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
3
Product Code
FWP
Prosthesis, Chin, Internal
2
Product Code
FYI
Appliance, Facial Fracture, External
1
Product Code
FZD
Prosthesis, Ear, Internal
2
Product Code
FZE
Prosthesis, Nose, Internal
2
Product Code
FZF
Splint, Extremity, Inflatable, External
1
Product Code
GBI
Material, External Aesthetic Restoration, Used With Adhesive
1
Product Code
GBJ
Prosthesis, Adhesive, External
1
Product Code
JCQ
Prosthesis, Esophagus
2
Product Code
KCZ
Prosthesis, Breast, External, Used With Adhesive
1
Product Code
KDA
Prosthesis, Ptfe/Carbon-Fiber
2
Product Code
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
2
Product Code
LZK
Implant, Malar
2
Product Code
MCA
Tape, Surgical, Internal
2
Product Code
MNF
Implant, Temporal
2
Product Code
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
1
Product Code
NOD
Board, Arm (With Cover), Non-Sterile
1
Product Code
NOJ
Prosthesis, Breast, External, No Adhesive
1
Product Code
NOK
Material, External Aesthetic Restoration, No Adhesive
1
Product Code
NWA
Prosthesis, Tracheal, Preformed/Molded
2
Product Code
NYT
Prosthesis, Tracheal, Expandable, Polymeric
2
Product Code
ODU
Facial Implant
2
Product Code
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OOD
Surgical Film
2
Product Code
OQL
Mesh, Surgical, Deployment Balloon
2
Product Code
ORQ
Mesh, Surgical, Deployer
2
Product Code
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
2
Product Code
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
2
Product Code
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
2
Product Code
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
2
Product Code
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
2
Product Code
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
2
Product Code
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
2
Product Code
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
2
Product Code
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
2
Product Code
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
2
Product Code
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
2
Product Code
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
2
Product Code
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
2
Product Code
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
2
Product Code
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
2
Product Code
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
2
Product Code
OXL
Mesh, Surgical, Absorbable, Organ Support
2
Product Code
OXM
Mesh, Surgical, Absorbable, Fistula
2
Product Code
OXN
Mesh, Surgical, Collagen, Fistula
2
Product Code
PIJ
Collagen Surgical Mesh Containing Drugs
2
Product Code
PQN
Carbon Dioxide Gas Controlled Tissue Expander
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-d—prosthetic-devices
/
FTM
/
K192616
View Source
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192616
510(k) Type
Special
Applicant
Aziyo Biologics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/21/2019
Days to Decision
28 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
ESF
Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
EZX
Mesh, Surgical, Metal
MIB
Elastomer, Silicone Block
MIC
Implant, Muscle, Pectoralis
BTX
Board, Arm (With Cover), Sterile
FTL
Mesh, Surgical, Polymeric
FTM
Mesh, Surgical
K
23
3991
CanGaroo RM Antibacterial Envelope
K
24
1126
OviTex PRS
K
22
3052
Peri-Guard and Supple Peri-Guard
K
21
4070
OviTex PRS (Long Term Resorbable)
K
21
3163
VersaWrap
K
21
3125
PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
K
20
3496
Nexo-Gide Bilayer Collagen Membrane
K
20
3600
VersaWrap
K
19
2452
Lyograft
K
20
1000
Biodesign Staple Line Reinforcement
K
20
1313
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
K
20
0311
VersaWrap Tendon Protector
K
19
2615
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
K
19
2616
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
K
18
2493
Bovine Pericardial Tissue Patch
K
18
3398
Endoform Restella
K
18
3472
DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
K
18
2259
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K
18
2255
CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
K
17
1817
Biodesign Diaphragmatic Hernia Graft
K
17
3242
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
K
17
2937
Colorado Therapeutics Xenograft Implant
K
16
2934
Biodesign Parastomal Hernia Repair Graft
K
17
0016
Biodesign Fistula Plug
K
17
0763
Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
K
16
2752
ARTIA Reconstructive Tissue Matrix Perforated
K
16
2965
SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
K
16
2570
Miromatrix Biological Mesh TW
K
16
2388
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
K
16
2461
Endoform Plastics and Reconstructive Matrix
K
16
2554
Gentrix Surgical Matrix
K
16
0181
COLORADO THERAPEUTICS XENOGRAFT IMPLANT
K
16
1221
Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
K
16
0869
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
K
15
3633
Endoform Reconstructive Template
K
15
2206
SurgiPure XD Reconstructive Tissue Matrix
K
15
0668
Biodesign Enterocutaneous Fistula Plug
K
14
2887
SIS Inguinal Hernia Repair Graft
K
15
0712
LTM-Perforated Surgical Mesh
K
14
1084
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
K
14
2326
HP Tissue Matrix
K
14
1721
BOVINE PERICARDIUM PATCH
K
14
1053
OVINE TISSUE MATRIX(OTM)
K
14
2070
FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
K
14
0306
CORMATRIX PROTECT ECM ENVELOPE
K
13
3306
SIS HERNIA GRAFT
K
14
0501
XENMATRIX SURGICAL GRAFT
K
13
4033
MIROMATRIX BIOLOGICAL MESH
K
13
2025
MESO BILAYER SURGICAL MESH
K
13
0547
ENDOFORM RECONSTRUCTIVE TEMPLATE
K
12
3356
FORTIVA PORCINE DERMIS
K
12
2048
COLLAGEN TENDON SHEET-D
K
12
0605
PERMACOL SURGICAL IMPLANT
K
12
0019
COLLAGEN RIBBON
K
11
3460
SYNERGY TISSUE MATRIX
K
11
0581
PROPATCH SOFT TISSUE REPAIR MATRIX
K
11
2423
COLLAGEN TENDON SHEET
K
11
2786
PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
K
11
1436
PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX
K
11
1584
XYLOS MACRO-POROUS SURGICAL MESH
K
11
0402
BIODESIGN NIPPLE RECONSTRUCTION CYLINDER
K
10
3787
MEDEOR MATRIX
K
10
1587
PROPATCH SOFT TISSUE REPAIR MATRIX
K
09
4061
KENSEY NASH ECM SURGICAL PATCH
K
09
1499
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
K
09
1142
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
K
09
0880
XYLOS POROUS SURGICAL MESH
K
09
0778
MTA PROTECTIVE SHEET
K
08
3823
SECURIAN TISSUE REINFORCEMENT MATRIX
K
08
2682
SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG
K
08
3898
SURGIMEND
K
08
3039
VERITAS COLLAGEN MATRIX (DRY)
K
08
2176
LTM-BPS SURGICAL MESH
K
08
2687
COLLAMEND FM IMPLANT
K
08
1272
PORCINE SURGICAL MESH; DERMAL MATRIX
K
08
1882
MODIFICATION TO XYLOS SURGICAL MESH
K
08
1538
TUTOPATCH, TUTOMESH
K
08
0452
COLLAGEN TENDON WRAP
K
07
3219
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08
K
07
3391
SURGISIS BIODESIGN TISSUE GRAFT
K
07
1986
LTM-RC SURGICAL MESH
K
07
0405
MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT
K
07
1016
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K
07
1807
ORTHOMEND SOFT TISSUE MATRIX
K
06
2558
MESOSFOL SURGICAL FILM
K
07
0560
LRTM SURGICAL MESH
K
07
1065
ORTHADAPT BIOIMPLANT
K
07
0738
SIS FACIAL CYLINDER, SIS FACIAL IMPLANT
K
06
3556
PERIPATCH ENDO-SLEEVE
K
06
2915
VERITAS COLLAGEN MATRIX
K
06
1892
PROPATCH SOFT TISSUE REPAIR MATRIX
K
06
3178
BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106
K
06
2696
SURGISIS, SURGISIS ES
K
06
2729
SURGISIS RVP RECTO-VAGINAL FISTULA PLUG
K
06
2320
SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100
K
05
3562
ZIMMER COLLAGEN REPAIR PATCH
K
06
0984
XENFORM SOFT TISSUE REPAIR MATRIX
K
06
0829
COSMATRIX
K
06
0989
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K
06
1030
BIOBLANKET SURGICAL MESH
K
05
2322
BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105
K
05
3655
TENDON WRAP TENDON PROTECTOR
K
05
1879
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS
K
05
1048
SURGISIS STAPLE LINE REINFORCEMENT II
K
04
3259
BIOBLANKET SURGICAL MESH
K
04
3388
PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH
K
05
0246
SIS DERMAL AUGMENTATION STRAND
K
05
0337
SIS FISTULA PLUG
K
04
2809
CUFFPATCH
K
04
1669
VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD
K
04
1923
BIOBLANKET
K
04
0756
THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
K
04
1140
ACELL UBM SURGICAL MESH ML AND MLPLUS
K
04
0364
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH
K
04
0835
PERIPATCH SHEET, MODELS 1.5P8, 1.5P16, 4P4, 4P6, 6P8 AND 10P16
K
04
0868
SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH
K
03
3985
PERIPATCH SLEEVE, MODELS G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10
K
04
0621
ACELL UBM SURGICAL MESH
K
04
0119
PERI-STRIPS STAPLE LINE REINFORCEMENT-SLEEVE CONFIGURATION, PERI-STRIPS STAPLE LINE REINFORCEMENT-STRIP CONFIGURATION
K
03
4039
SIS PLASTIC SURGERY MATRIX
K
03
1969
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K
03
1332
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K
03
0782
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K
02
3237
XYLOS SURGICAL MESH
K
02
1056
PERMACOL
K
02
1160
DERMMATRIX SURGICAL MESH
K
02
1107
FORTAFLEX SURGICAL SLING
K
02
1105
FORTAFLEX SURGICAL MESH
K
02
0455
TISSUEMEND SOFT TISSUE REPAIR MATRIX
K
02
0049
FORTAFLEX SURGICAL MESH
K
01
3625
PERMACOL
K
01
1025
FORTAFLEX SURGICAL MESH
K
01
1027
FORTAFLEX SURGICAL SLING
K
00
1738
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K
99
1296
TUTOPATCH
K
99
2537
PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED
K
99
1567
SHELHIGH NO-REACT TISSUE REPAIR PATCH/UROPATCH.
K
98
3162
PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC
K
98
2330
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K
98
0431
SURGISIS
K
97
3379
STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS
K
97
1048
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K
96
3175
GLYCAR TISSUE REPAIR PATCH, BIO-PATCH, URO-SLING
K
96
1810
SUPPLE PERI-GUARD PERICARDIUM
K
96
1811
PERI-GUARD PERICARDIUM
K
94
0205
PERI-STRIPS
K
92
2308
TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER
K
92
3657
SUPPLE PERI-GUARD
K
91
5774
PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH
K
89
6946
COATED NOVAFIL, POLYBUTESTER, MESH
K
89
4580
GORE-TEX SURGICAL TAPE
K
85
2011
NYLAMID MESH PAD FULL & HALF
K
85
1086
VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH
K
84
4228
PDS POLYDIOXANONE MESH
K
84
4225
LINK ACETABULAR MESH
K
83
1725
FOIL IN 3 FORMS-NON-STERILE SHEETS
K
83
1727
QUARTER GLOBE CAPS
K
83
1723
SUPRAMID EXTRA SURGICAL MESH
K
83
1726
EYE MUSCLE SLEEVES
K
83
0889
DEXON 'S' POLYGLYCOLIC ACID MESH
K
82
0619
MECRON(R) ACETABULAR NETS TM
FTN
Plastic Surgery And Accessories Kit
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FWP
Prosthesis, Chin, Internal
FYI
Appliance, Facial Fracture, External
FZD
Prosthesis, Ear, Internal
FZE
Prosthesis, Nose, Internal
FZF
Splint, Extremity, Inflatable, External
GBI
Material, External Aesthetic Restoration, Used With Adhesive
GBJ
Prosthesis, Adhesive, External
JCQ
Prosthesis, Esophagus
KCZ
Prosthesis, Breast, External, Used With Adhesive
KDA
Prosthesis, Ptfe/Carbon-Fiber
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
LZK
Implant, Malar
MCA
Tape, Surgical, Internal
MNF
Implant, Temporal
NOC
Splint, Extremity, Non-Inflatable, External, Non-Sterile
NOD
Board, Arm (With Cover), Non-Sterile
NOJ
Prosthesis, Breast, External, No Adhesive
NOK
Material, External Aesthetic Restoration, No Adhesive
NWA
Prosthesis, Tracheal, Preformed/Molded
NYT
Prosthesis, Tracheal, Expandable, Polymeric
ODU
Facial Implant
OXG
Mesh, Surgical, Non-Absorbable, Plastic And Reconstructive Surgery
OOD
Surgical Film
OQL
Mesh, Surgical, Deployment Balloon
ORQ
Mesh, Surgical, Deployer
OWR
Mesh, Surgical, Non-Absorbable, Facial Implants For Plastic Surgery
OWS
Mesh, Surgical, Collagen, Plastics, Facial Implants
OWT
Mesh, Surgical, Absorbable, Abdominal Hernia
OWU
Mesh, Surgical, Non-Absorbable, Diaphragmatic Hernia
OWV
Mesh, Surgical, Collagen, Diaphragmatic Hernia
OWW
Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWX
Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon
OWY
Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
OWZ
Mesh, Surgical, Absorbable, Thoracic, Chest Wall Reconstruction
OXA
Mesh, Surgical, Non-Absorbable, Thoracic, Chest Wall Reconstruction
OXB
Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction
OXC
Mesh, Surgical, Absorbable, Staple Line Reinforcement
OXD
Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement
OXE
Mesh, Surgical, Collagen, Staple Line Reinforcement
OXF
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
OXH
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
OXI
Mesh, Surgical, Absorbable, Large Abdominal Wall Defects
OXJ
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
OXK
Mesh, Surgical, Collagen, Large Abdominal Wall Defects
OXL
Mesh, Surgical, Absorbable, Organ Support
OXM
Mesh, Surgical, Absorbable, Fistula
OXN
Mesh, Surgical, Collagen, Fistula
PIJ
Collagen Surgical Mesh Containing Drugs
PQN
Carbon Dioxide Gas Controlled Tissue Expander
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-d—prosthetic-devices
/
FTM
/
K192616
View Source
CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192616
510(k) Type
Special
Applicant
Aziyo Biologics, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/21/2019
Days to Decision
28 days
Submission Type
Summary