The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Conserve Thin Shell.
Device ID | K113322 |
510k Number | K113322 |
Device Name: | CONSERVE THIN SHELL |
Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Matt Paul |
Correspondent | Matt Paul WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | KWA |
CFR Regulation Number | 888.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-10 |
Decision Date | 2012-02-03 |
Summary: | summary |