The following data is part of a premarket notification filed by Integrated Orbital Implants, Inc. with the FDA for Motility Orbital Implant.
| Device ID | K891137 |
| 510k Number | K891137 |
| Device Name: | MOTILITY ORBITAL IMPLANT |
| Classification | Implant, Eye Sphere |
| Applicant | INTEGRATED ORBITAL IMPLANTS, INC. 9834 GENESEE AVE. SUITE 315 La Jolla, CA 92037 |
| Contact | Perry, M.d. |
| Correspondent | Perry, M.d. INTEGRATED ORBITAL IMPLANTS, INC. 9834 GENESEE AVE. SUITE 315 La Jolla, CA 92037 |
| Product Code | HPZ |
| CFR Regulation Number | 886.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-08-24 |