The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Advantage Fixation Screw System.
| Device ID | K961234 |
| 510k Number | K961234 |
| Device Name: | DEPUY ADVANTAGE FIXATION SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Sally Foust |
| Correspondent | Sally Foust DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-29 |
| Decision Date | 1996-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705010516 | K961234 | 000 |
| 10886705010349 | K961234 | 000 |
| 10886705010356 | K961234 | 000 |
| 10886705010363 | K961234 | 000 |
| 10886705010370 | K961234 | 000 |
| 10886705010387 | K961234 | 000 |
| 10886705010394 | K961234 | 000 |
| 10886705010400 | K961234 | 000 |
| 10886705010417 | K961234 | 000 |
| 10886705010424 | K961234 | 000 |
| 10886705010431 | K961234 | 000 |
| 10886705010448 | K961234 | 000 |
| 10886705010455 | K961234 | 000 |
| 10886705010462 | K961234 | 000 |
| 10886705010479 | K961234 | 000 |
| 10886705010486 | K961234 | 000 |
| 10886705010493 | K961234 | 000 |
| 10886705010509 | K961234 | 000 |
| 10886705010332 | K961234 | 000 |