The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Trochanter Cable Grip System (add'l Indications).
| Device ID | K900926 |
| 510k Number | K900926 |
| Device Name: | TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) |
| Classification | Wire, Surgical |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Mary C Spicer |
| Correspondent | Mary C Spicer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | LRN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-27 |
| Decision Date | 1990-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327036473 | K900926 | 000 |
| 07613327036459 | K900926 | 000 |
| 07613327036398 | K900926 | 000 |
| 07613327036381 | K900926 | 000 |
| 07613327013351 | K900926 | 000 |
| 07613327013344 | K900926 | 000 |
| 07613327013337 | K900926 | 000 |