The following data is part of a premarket notification filed by Depuyacromed with the FDA for Bowti Anterior Buttress Staple System.
| Device ID | K021039 |
| 510k Number | K021039 |
| Device Name: | BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUYACROMED 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Karen F Jurczak |
| Correspondent | Karen F Jurczak DEPUYACROMED 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-01 |
| Decision Date | 2002-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034015682 | K021039 | 000 |
| 10705034015675 | K021039 | 000 |
| 10705034015668 | K021039 | 000 |
| 10705034015651 | K021039 | 000 |
| 10705034015644 | K021039 | 000 |