The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Osteomed Great Toe System.
| Device ID | K922211 |
| 510k Number | K922211 |
| Device Name: | OSTEOMED GREAT TOE SYSTEM |
| Classification | Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained |
| Applicant | OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Contact | Steven C Pubols |
| Correspondent | Steven C Pubols OSTEOMED CORP. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Product Code | LZJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-12 |
| Decision Date | 1993-11-09 |