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by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
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Review Panel
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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
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
HPZ
Implant, Eye Sphere
2
Product Code
K
12
3764
DURETTE OCULAR IMPLANT
2
Cleared 510(K)
K
11
0554
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
2
Cleared 510(K)
K
11
2176
SILICONE SPHERES
2
Cleared 510(K)
K
08
3342
ORBITAL RECONSTRUCTIVE IMPLANT II
2
Cleared 510(K)
K
08
2850
EYE SPHERES
2
Cleared 510(K)
K
07
3293
DURETTE IMPLANT
2
Cleared 510(K)
K
07
1335
MEDPOR ATTRACTOR IMPLANT
2
Cleared 510(K)
K
07
0130
ORBITAL RECONSTRUCTIVE IMPLANT
2
Cleared 510(K)
K
05
3298
ALPHASPHERE ORBITAL IMPLANT
2
Cleared 510(K)
K
04
0851
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
2
Cleared 510(K)
K
04
0689
EYE SPHERE IMPLANTS
2
Cleared 510(K)
K
02
3400
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
2
Cleared 510(K)
K
02
1643
HA ORBITAL IMPLANT
2
Cleared 510(K)
K
02
1357
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
2
Cleared 510(K)
K
01
0902
MEDPOR QUAD MOTILITY IMPLANT
2
Cleared 510(K)
K
00
3338
BIO-EYE II ORBITAL IMPLANT
2
Cleared 510(K)
K
99
2294
BIOCERAMIC ORBITAL IMPLANT
2
Cleared 510(K)
K
98
2562
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
2
Cleared 510(K)
K
97
2143
MOA BONE / M-SPHERE
2
Cleared 510(K)
K
97
2661
EYE SPHERE, CONFORMERS
2
Cleared 510(K)
K
96
2241
GORE SPHEREX IMPLANT
2
Cleared 510(K)
K
96
0859
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
95
4939
MEDPOR OCULAR SCREW & ACCESSORIES
2
Cleared 510(K)
K
94
1717
MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT
2
Cleared 510(K)
K
94
3275
MEDPOR SURGICAL IMPLANT MATERIAL
2
Cleared 510(K)
K
93
4834
EPTFE SHEET COVERING FOR OCULAR IMPLANT
2
Cleared 510(K)
K
93
5251
MARTINEZ ORBITAL IMPLANT
2
Cleared 510(K)
K
92
1106
STERILE/SINGLE USE EYE SPHERE IMPLANTS
2
Cleared 510(K)
K
91
5630
OPHTIMPLANT
2
Cleared 510(K)
K
91
1110
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
2
Cleared 510(K)
K
90
0080
NEW IOWA MOTILITY IMPLANT
2
Cleared 510(K)
K
90
0081
NEW ALLEN IMPLANT
2
Cleared 510(K)
K
89
5908
MULES SPHERE GLASS (SEVERAL SIZES)
2
Cleared 510(K)
K
89
1137
MOTILITY ORBITAL IMPLANT
2
Cleared 510(K)
K
87
3578
LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT
2
Cleared 510(K)
K
86
3943
POREX(TM) EYE SPHERE IMPLANT
2
Cleared 510(K)
K
86
2977
MEDITRADE ARTIFICIAL EYES AND IMPLANTS
2
Cleared 510(K)
K
78
1356
IMPLANT, EYE SPHERE
2
Cleared 510(K)
HQH
Eye, Artificial, Non-Custom
1
Product Code
HQJ
Implant, Absorbable, (Scleral Buckling Methods)
2
Product Code
HQL
Intraocular Lens
3
Product Code
HQM
Keratoprosthesis, Permanent Implant
2
Product Code
HQN
Conformer, Ophthalmic
2
Product Code
HQT
Shell, Scleral
2
Product Code
HQW
Clip, Tantalum, Ophthalmic
2
Product Code
HQX
Implant, Orbital, Extra-Ocular
2
Product Code
KYF
Implant, Eye Valve
2
Product Code
MFK
Lens, Multifocal Intraocular
3
Product Code
MJP
Lens, Intraocular, Toric Optics
3
Product Code
MLP
Keratoprosthesis, Temporary Implant, Surgical Use
2
Product Code
MQU
Ocular Peg
2
Product Code
MTZ
Wrap, Implant, Orbital
2
Product Code
NAA
Lens, Intraocular, Accommodative
3
Product Code
NCK
Button, Iris, Eye, Artificial
1
Product Code
NFM
Expander, Tissue, Orbital
2
Product Code
NIZ
Lens, Iris Reconstruction
3
Product Code
NQB
Conformer, Ophthalmic, Biological Tissue
2
Product Code
NXM
Prosthesis, Eyelid Spacer/Graft, Biologic
2
Product Code
POE
Extended Depth Of Focus Intraocular Lens
3
Product Code
PUF
Ocular Peg, Exempt
2
Product Code
PZK
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
3
Product Code
QCB
Phakic Toric Intraocular Lens
3
Product Code
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
OP
/
prosthetic-devices
/
HPZ
/
K943275
View Source
MEDPOR SURGICAL IMPLANT MATERIAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K943275
510(k) Type
Traditional
Applicant
POREX SURGICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/2/1994
Days to Decision
57 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
HPZ
Implant, Eye Sphere
K
12
3764
DURETTE OCULAR IMPLANT
K
11
0554
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
K
11
2176
SILICONE SPHERES
K
08
3342
ORBITAL RECONSTRUCTIVE IMPLANT II
K
08
2850
EYE SPHERES
K
07
3293
DURETTE IMPLANT
K
07
1335
MEDPOR ATTRACTOR IMPLANT
K
07
0130
ORBITAL RECONSTRUCTIVE IMPLANT
K
05
3298
ALPHASPHERE ORBITAL IMPLANT
K
04
0851
MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM
K
04
0689
EYE SPHERE IMPLANTS
K
02
3400
FCI MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT
K
02
1643
HA ORBITAL IMPLANT
K
02
1357
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K
01
0902
MEDPOR QUAD MOTILITY IMPLANT
K
00
3338
BIO-EYE II ORBITAL IMPLANT
K
99
2294
BIOCERAMIC ORBITAL IMPLANT
K
98
2562
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K
97
2143
MOA BONE / M-SPHERE
K
97
2661
EYE SPHERE, CONFORMERS
K
96
2241
GORE SPHEREX IMPLANT
K
96
0859
MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
K
95
4939
MEDPOR OCULAR SCREW & ACCESSORIES
K
94
1717
MARTINEZ HYDROXYLAPATITE ORBITAL IMPLANT
K
94
3275
MEDPOR SURGICAL IMPLANT MATERIAL
K
93
4834
EPTFE SHEET COVERING FOR OCULAR IMPLANT
K
93
5251
MARTINEZ ORBITAL IMPLANT
K
92
1106
STERILE/SINGLE USE EYE SPHERE IMPLANTS
K
91
5630
OPHTIMPLANT
K
91
1110
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
K
90
0080
NEW IOWA MOTILITY IMPLANT
K
90
0081
NEW ALLEN IMPLANT
K
89
5908
MULES SPHERE GLASS (SEVERAL SIZES)
K
89
1137
MOTILITY ORBITAL IMPLANT
K
87
3578
LEE ALLEN'S UNIVERSAL MOTILITY IMPLANT
K
86
3943
POREX(TM) EYE SPHERE IMPLANT
K
86
2977
MEDITRADE ARTIFICIAL EYES AND IMPLANTS
K
78
1356
IMPLANT, EYE SPHERE
HQH
Eye, Artificial, Non-Custom
HQJ
Implant, Absorbable, (Scleral Buckling Methods)
HQL
Intraocular Lens
HQM
Keratoprosthesis, Permanent Implant
HQN
Conformer, Ophthalmic
HQT
Shell, Scleral
HQW
Clip, Tantalum, Ophthalmic
HQX
Implant, Orbital, Extra-Ocular
KYF
Implant, Eye Valve
MFK
Lens, Multifocal Intraocular
MJP
Lens, Intraocular, Toric Optics
MLP
Keratoprosthesis, Temporary Implant, Surgical Use
MQU
Ocular Peg
MTZ
Wrap, Implant, Orbital
NAA
Lens, Intraocular, Accommodative
NCK
Button, Iris, Eye, Artificial
NFM
Expander, Tissue, Orbital
NIZ
Lens, Iris Reconstruction
NQB
Conformer, Ophthalmic, Biological Tissue
NXM
Prosthesis, Eyelid Spacer/Graft, Biologic
POE
Extended Depth Of Focus Intraocular Lens
PUF
Ocular Peg, Exempt
PZK
Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)
QCB
Phakic Toric Intraocular Lens
Surgical Devices
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
prosthetic-devices
/
HPZ
/
K943275
View Source
MEDPOR SURGICAL IMPLANT MATERIAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K943275
510(k) Type
Traditional
Applicant
POREX SURGICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/2/1994
Days to Decision
57 days
Submission Type
Statement