FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
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
Review Panel
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
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
K
23
2593
FITme Customized Silicone Implant
2
Cleared 510(K)
K
20
0610
Customized Contour Implant
2
Cleared 510(K)
K
19
1130
Customized Contour Implant
2
Cleared 510(K)
K
19
1916
Stryker CMF MEDPOR Priority Customized Implant Kit
2
Cleared 510(K)
K
15
3508
Stryker CMF MEDPOR Customized Implant
2
Cleared 510(K)
K
15
2463
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
2
Cleared 510(K)
K
14
3173
Stryker CMF MEDPOR Customized Implant
2
Cleared 510(K)
K
14
1027
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
2
Cleared 510(K)
K
12
1315
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
2
Cleared 510(K)
K
09
1011
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
2
Cleared 510(K)
K
02
1417
AART CHIN IMPLANT
2
Cleared 510(K)
K
01
2350
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
2
Cleared 510(K)
K
99
2239
PILLAR CHIN IMPLANT
2
Cleared 510(K)
K
98
3754
STANDARD CHIN
2
Cleared 510(K)
K
98
2752
SEARE BIOMEDICAL CHIN IMPLANTS
2
Cleared 510(K)
K
98
1850
SILIMED CHIN IMPLANTS
2
Cleared 510(K)
K
98
0446
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
2
Cleared 510(K)
K
98
0463
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
2
Cleared 510(K)
K
98
0462
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
2
Cleared 510(K)
K
98
0444
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
2
Cleared 510(K)
K
98
0445
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
2
Cleared 510(K)
K
98
0138
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
2
Cleared 510(K)
K
98
0461
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
2
Cleared 510(K)
K
97
3575
DURALASTIC ANATOMICAL CHIN IMPLANTS
2
Cleared 510(K)
K
97
1478
DURALASTIC ANATOMICAL CHIN IMPLANTS
2
Cleared 510(K)
K
96
1071
THE MAGNUM CHIN IMPLANT
2
Cleared 510(K)
K
96
0349
PERMARIDGE HYDROXYLAPATITE MATRIX
2
Cleared 510(K)
K
95
2677
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
2
Cleared 510(K)
K
94
6267
GORE-TEX SAM FACIAL IMPLANT
2
Cleared 510(K)
K
94
5998
CHIN IMPLANT STYLE I
2
Cleared 510(K)
K
92
5610
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
2
Cleared 510(K)
K
93
1500
THE PERMARIDGE MATRIX CHIN
2
Cleared 510(K)
K
94
3644
IMPLANTECH TEMPORAL IMPLANT
2
Cleared 510(K)
K
94
2280
GORETEX SAM FACIAL IMPLANT
2
Cleared 510(K)
K
93
3367
GORE-TEX FACIAL IMPLANT
2
Cleared 510(K)
K
92
2489
MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
2
Cleared 510(K)
K
92
1581
CHIN WAFER
2
Cleared 510(K)
K
91
4297
K.D. CHIN IMPLANT
2
Cleared 510(K)
K
91
3761
3-D ACCUSCAN FACIAL IMPLANTS
2
Cleared 510(K)
K
91
1516
HIGH PROFILE CHIN IMPLANT
2
Cleared 510(K)
K
91
1514
ARTICULATED CHIN IMPLANT
2
Cleared 510(K)
K
91
0456
ZARA CHIN IMPLANT
2
Cleared 510(K)
K
91
0457
ZARA EXTENDED CHIN IMPLANT
2
Cleared 510(K)
K
91
0458
ZARA SOFT TIP CHIN IMPLANT
2
Cleared 510(K)
K
90
5268
FLOWERS JOWL IMPLANT
2
Cleared 510(K)
K
90
5267
FLOWERS CHIN IMPLANT
2
Cleared 510(K)
K
90
4349
CUI CURVILINEAR SILICONE CHIN
2
Cleared 510(K)
K
90
2285
THE MAGNUM CHIN IMPLANT
2
Cleared 510(K)
K
90
3327
CUI ARTICULATED SILICONE CHIN
2
Cleared 510(K)
K
90
2941
CURVILINEAR SILICONE CHIN IMPLANT
2
Cleared 510(K)
K
90
2825
EXTENDED CHIN IMPLANT STYLE II
2
Cleared 510(K)
K
90
2827
ANATOMICAL MANDIBULAR IMPLANT STYLE II
2
Cleared 510(K)
K
90
2826
ANATOMICAL MANDIBULAR IMPLANT STYLE I
2
Cleared 510(K)
K
90
2824
EXTENDED CHIN IMPLANT STYLE I
2
Cleared 510(K)
K
87
1070
OMEGA SILICONE CHIN IMPLANT
2
Cleared 510(K)
K
87
1190
ANADIAS ZARA SYSTEM MALAR IMPLANTS
2
Cleared 510(K)
K
87
1074
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
2
Cleared 510(K)
K
86
3941
POREX(TM) PROSTHESIS, CHIN, INTERNAL
2
Cleared 510(K)
K
86
3397
BYRON SILICONE CHIN IMPLANTS
2
Cleared 510(K)
K
83
2283
MEDPAR SURGICAL IMPLANTS
2
Cleared 510(K)
K
83
2148
PDM SILOXANE PROSTHETIC CHIN IMPLANT
2
Cleared 510(K)
K
83
1724
CHIN (MENTOPLASTY) IMPLANTS
2
Cleared 510(K)
K
81
2210
CREAT BRAND WAGNER CHIN IMPLANT
2
Cleared 510(K)
K
80
1073
STRAITH CHIN IMPLANTS
2
Cleared 510(K)
K
76
0562
CHIN IMPLANTS
2
Cleared 510(K)
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
/
FWP
/
K871074
View Source
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871074
510(k) Type
Traditional
Applicant
OMEGA SILICONE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/1987
Days to Decision
23 days
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
FTN
Plastic Surgery And Accessories Kit
FTR
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
FWM
Prosthesis, Breast, Inflatable, Internal, Saline
FWP
Prosthesis, Chin, Internal
K
23
2593
FITme Customized Silicone Implant
K
20
0610
Customized Contour Implant
K
19
1130
Customized Contour Implant
K
19
1916
Stryker CMF MEDPOR Priority Customized Implant Kit
K
15
3508
Stryker CMF MEDPOR Customized Implant
K
15
2463
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant
K
14
3173
Stryker CMF MEDPOR Customized Implant
K
14
1027
3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP
K
12
1315
STRYKER CMF MEDPOR CUSTOMIZED IMPLANT
K
09
1011
PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)
K
02
1417
AART CHIN IMPLANT
K
01
2350
MEDPOR PLUS SURGICAL IMPLANT BIOMATERIAL
K
99
2239
PILLAR CHIN IMPLANT
K
98
3754
STANDARD CHIN
K
98
2752
SEARE BIOMEDICAL CHIN IMPLANTS
K
98
1850
SILIMED CHIN IMPLANTS
K
98
0446
SPECTRUM DESIGNS ANTERIOR CHIN IMPLANT
K
98
0463
SPECTRUM DESIGNS CURVILINEAR CHIN IMPLANT
K
98
0462
SPECTRUM DESIGNS ANATOMICAL CHIN IMPLANT
K
98
0444
SPECTRUM DESIGNS BILATERAL GROOVE CHIN IMPLANT
K
98
0445
SPECTRUM DESIGNS CONCAVE BACK CHIN IMPLANT
K
98
0138
SPECTRUM DESIGNS SYMMETRICAL CHIN IMPLANT
K
98
0461
SPECTRUM DESIGNS CLEFT CHIN IMPLANT
K
97
3575
DURALASTIC ANATOMICAL CHIN IMPLANTS
K
97
1478
DURALASTIC ANATOMICAL CHIN IMPLANTS
K
96
1071
THE MAGNUM CHIN IMPLANT
K
96
0349
PERMARIDGE HYDROXYLAPATITE MATRIX
K
95
2677
MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIAL
K
94
6267
GORE-TEX SAM FACIAL IMPLANT
K
94
5998
CHIN IMPLANT STYLE I
K
92
5610
FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
K
93
1500
THE PERMARIDGE MATRIX CHIN
K
94
3644
IMPLANTECH TEMPORAL IMPLANT
K
94
2280
GORETEX SAM FACIAL IMPLANT
K
93
3367
GORE-TEX FACIAL IMPLANT
K
92
2489
MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLA
K
92
1581
CHIN WAFER
K
91
4297
K.D. CHIN IMPLANT
K
91
3761
3-D ACCUSCAN FACIAL IMPLANTS
K
91
1516
HIGH PROFILE CHIN IMPLANT
K
91
1514
ARTICULATED CHIN IMPLANT
K
91
0456
ZARA CHIN IMPLANT
K
91
0457
ZARA EXTENDED CHIN IMPLANT
K
91
0458
ZARA SOFT TIP CHIN IMPLANT
K
90
5268
FLOWERS JOWL IMPLANT
K
90
5267
FLOWERS CHIN IMPLANT
K
90
4349
CUI CURVILINEAR SILICONE CHIN
K
90
2285
THE MAGNUM CHIN IMPLANT
K
90
3327
CUI ARTICULATED SILICONE CHIN
K
90
2941
CURVILINEAR SILICONE CHIN IMPLANT
K
90
2825
EXTENDED CHIN IMPLANT STYLE II
K
90
2827
ANATOMICAL MANDIBULAR IMPLANT STYLE II
K
90
2826
ANATOMICAL MANDIBULAR IMPLANT STYLE I
K
90
2824
EXTENDED CHIN IMPLANT STYLE I
K
87
1070
OMEGA SILICONE CHIN IMPLANT
K
87
1190
ANADIAS ZARA SYSTEM MALAR IMPLANTS
K
87
1074
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
K
86
3941
POREX(TM) PROSTHESIS, CHIN, INTERNAL
K
86
3397
BYRON SILICONE CHIN IMPLANTS
K
83
2283
MEDPAR SURGICAL IMPLANTS
K
83
2148
PDM SILOXANE PROSTHETIC CHIN IMPLANT
K
83
1724
CHIN (MENTOPLASTY) IMPLANTS
K
81
2210
CREAT BRAND WAGNER CHIN IMPLANT
K
80
1073
STRAITH CHIN IMPLANTS
K
76
0562
CHIN IMPLANTS
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
/
FWP
/
K871074
View Source
OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871074
510(k) Type
Traditional
Applicant
OMEGA SILICONE, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/1987
Days to Decision
23 days