The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Anterior Approach Hip Surgery Instruments.
Device ID | K102565 |
510k Number | K102565 |
Device Name: | ANTERIOR APPROACH HIP SURGERY INSTRUMENTS |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Gregory Neal |
Correspondent | Gregory Neal WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | KWA |
Subsequent Product Code | JDI |
Subsequent Product Code | JDL |
Subsequent Product Code | LWJ |
Subsequent Product Code | LZO |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-09-07 |
Decision Date | 2010-12-22 |
Summary: | summary |