The following data is part of a premarket notification filed by Advanced Biosearch Assn. with the FDA for Natural Lock Acetabular Component.
Device ID | K830662 |
510k Number | K830662 |
Device Name: | NATURAL LOCK ACETABULAR COMPONENT |
Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
Applicant | ADVANCED BIOSEARCH ASSN. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JDL |
CFR Regulation Number | 888.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-03 |
Decision Date | 1983-04-11 |