The following data is part of a premarket notification filed by Sutter Corp. with the FDA for Sutter Hammertoe Joint Prosthesis.
| Device ID | K943354 |
| 510k Number | K943354 |
| Device Name: | SUTTER HAMMERTOE JOINT PROSTHESIS |
| Classification | Prosthesis, Toe, Constrained, Polymer |
| Applicant | SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
| Contact | Louise Focht |
| Correspondent | Louise Focht SUTTER CORP. 9425 CHESAPEAKE DR. San Diego, CA 92123 |
| Product Code | KWH |
| CFR Regulation Number | 888.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-12 |
| Decision Date | 1995-06-12 |