The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Lineage Acetabular System.
Device ID | K002149 |
510k Number | K002149 |
Device Name: | LINEAGE ACETABULAR SYSTEM |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Ehab M Esmail |
Correspondent | Ehab M Esmail WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | LPH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-17 |
Decision Date | 2000-08-31 |
Summary: | summary |