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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
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)
Show All 38 Submissions
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
/
K110554
View Source
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110554
510(k) Type
Traditional
Applicant
CERAMISYS LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2011
Days to Decision
247 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
Show All 38 Submissions
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
/
K110554
View Source
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K110554
510(k) Type
Traditional
Applicant
CERAMISYS LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/2/2011
Days to Decision
247 days
Submission Type
Statement