FDA Registration
Active
🇺🇸 United States
INTEGRATED ORBITAL IMPLANTS, INC.
Reg #: 2027377
·
FEI: 3009688114
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- INTEGRATED ORBITAL IMPLANTS, INC.
- Registration Number
- 2027377
- FEI Number
- 3009688114
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11230 Sorrento Valley Rd Ste 135
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92121
- Country
- US
Regulatory Submissions
- 510(k) Number
- K891137
Owner / Operator
- Firm Name
- INTEGRATED ORBITAL IMPLANTS INC
- Operator Number
- 2027377
- Address
- 11230 Sorrento Valley Rd Ste 135, --
- City
- San Diego
- State
- CA
- Postal Code
- 92121
- Country
- US
- Correspondent
- Vicki - Perry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2006-12-11 |
| Implant, Eye Sphere | HPZ | Class 2 | Ophthalmic | No | 2007-11-13 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2024-02-29 |
| Ocular Peg | MQU | Class 2 | Ophthalmic | No | 2007-11-13 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 2007-11-13 |
Proprietary Names
Needle, ophthalmic suturing
IMPLANT, EYE SPHERE
THREADED SLEEVE DRIVER
THREADED SLEEVE WRENCH
OCULAR PEG
Sterile Bio-eye Ha implant & conf.
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility