The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Wright Medical Technology Sawblades.
Device ID | K955229 |
510k Number | K955229 |
Device Name: | WRIGHT MEDICAL TECHNOLOGY 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 | 1995-11-14 |
Decision Date | 1996-01-18 |