FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
K Number: K982562
·
Decision Dec 28, 1998
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
38
Applicant Total
5
Review Days
158
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Basic Information
- Device Name
- BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER
- K Number
- K982562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.3320
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Integrated Orbital Implants, Inc.
- Date Received
- July 23, 1998
- Decision Date
- December 28, 1998
- Product Code
- HPZ
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | FDA class 2 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HPZ), ordered by most recent decision date.
EZYPOR
FDA 510(k)
FDA Class 2
·Ophthalmic
DURETTE OCULAR IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
BIOCERAMIC ORBITAL IMPLANT, ORBTEX
FDA 510(k)
FDA Class 2
·Ophthalmic
SILICONE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
ORBITAL RECONSTRUCTIVE IMPLANT II
FDA 510(k)
FDA Class 2
·Ophthalmic
EYE SPHERES
FDA 510(k)
FDA Class 2
·Ophthalmic
Other Clearances by Integrated Orbital Implants, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K003338 | BIO-EYE II ORBITAL IMPLANT | Feb 7, 2001 | Substantially Equivalent |
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | Apr 10, 2000 | Substantially Equivalent |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | Feb 4, 1998 | Substantially Equivalent |
| K891137 | MOTILITY ORBITAL IMPLANT | Aug 24, 1989 | Substantially Equivalent |