The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Graft Harvesting Sawblades.
| Device ID | K971978 |
| 510k Number | K971978 |
| Device Name: | GRAFT HARVESTING SAWBLADES |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Cristie Manuel |
| Correspondent | Cristie Manuel WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-06-18 |
| Summary: | summary |