The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Low Profile Bone Screw.
| Device ID | K970929 |
| 510k Number | K970929 |
| Device Name: | DEPUY LOW PROFILE BONE SCREW |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-13 |
| Decision Date | 1997-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295007708 | K970929 | 000 |
| 10603295007609 | K970929 | 000 |
| 10603295007616 | K970929 | 000 |
| 10603295007623 | K970929 | 000 |
| 10603295007630 | K970929 | 000 |
| 10603295007647 | K970929 | 000 |
| 10603295007654 | K970929 | 000 |
| 10603295007661 | K970929 | 000 |
| 10603295007678 | K970929 | 000 |
| 10603295007685 | K970929 | 000 |
| 10603295007692 | K970929 | 000 |
| 10603295007593 | K970929 | 000 |