The following data is part of a premarket notification filed by Omni Life Science, Inc. with the FDA for Apex-lnk Poly Acetabular Cup Liners.
Device ID | K073150 |
510k Number | K073150 |
Device Name: | APEX-LNK POLY ACETABULAR CUP LINERS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
Applicant | OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
Contact | Edward J Cheal |
Correspondent | Edward J Cheal OMNI LIFE SCIENCE, INC. 175 PARAMOUNT DRIVE Raynham, MA 02767 |
Product Code | LPH |
Subsequent Product Code | LZO |
Subsequent Product Code | MEH |
CFR Regulation Number | 888.3358 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-08 |
Decision Date | 2008-02-27 |
Summary: | summary |