The following data is part of a premarket notification filed by Medimix Products, Inc. with the FDA for Mod. Trochanter Screw & Washer W/ Anodized Titan..
| Device ID | K910664 |
| 510k Number | K910664 |
| Device Name: | MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN. |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Uncemented |
| Applicant | MEDIMIX PRODUCTS, INC. 860 CANAL ST. Stamford, CT 06902 |
| Contact | Debra Bing |
| Correspondent | Debra Bing MEDIMIX PRODUCTS, INC. 860 CANAL ST. Stamford, CT 06902 |
| Product Code | LWJ |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-14 |
| Decision Date | 1992-04-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295178170 | K910664 | 000 |
| 10603295173458 | K910664 | 000 |
| 10603295173465 | K910664 | 000 |
| 10603295173472 | K910664 | 000 |
| 10603295173489 | K910664 | 000 |
| 10603295173496 | K910664 | 000 |
| 10603295171430 | K910664 | 000 |
| 10603295171447 | K910664 | 000 |
| 10603295171454 | K910664 | 000 |
| 10603295171461 | K910664 | 000 |
| 10603295178156 | K910664 | 000 |
| 10603295178163 | K910664 | 000 |
| 10603295173441 | K910664 | 000 |