The following data is part of a premarket notification filed by Biomechanic, Inc. with the FDA for Biomechanic Low-profile Cable System.
| Device ID | K951844 |
| 510k Number | K951844 |
| Device Name: | BIOMECHANIC LOW-PROFILE CABLE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | BIOMECHANIC, INC. 12634 OLIVE BLVD. Creve Coeur, MO 63141 |
| Contact | Michael Wall |
| Correspondent | Michael Wall BIOMECHANIC, INC. 12634 OLIVE BLVD. Creve Coeur, MO 63141 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-20 |
| Decision Date | 1995-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B046BIO110120 | K951844 | 000 |
| B046BIO11012A0 | K951844 | 000 |