The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Hoffmann Ii Carbon Connecting Rod.
| Device ID | K961916 |
| 510k Number | K961916 |
| Device Name: | HOFFMANN II CARBON CONNECTING ROD |
| Classification | Component, Traction, Invasive |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327079654 | K961916 | 000 |
| 07613327079296 | K961916 | 000 |
| 07613327079326 | K961916 | 000 |
| 07613327079357 | K961916 | 000 |
| 07613327079364 | K961916 | 000 |
| 07613327079388 | K961916 | 000 |
| 07613327079418 | K961916 | 000 |
| 07613327079456 | K961916 | 000 |
| 07613327079531 | K961916 | 000 |
| 07613327079548 | K961916 | 000 |
| 07613327079555 | K961916 | 000 |
| 07613327079579 | K961916 | 000 |
| 07613327079593 | K961916 | 000 |
| 07613327079616 | K961916 | 000 |
| 07613327079630 | K961916 | 000 |
| 07613327079265 | K961916 | 000 |