The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Microstructured Spherical Acetabular Components.
Device ID | K870216 |
510k Number | K870216 |
Device Name: | MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS |
Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Contact | Dennis H Crane |
Correspondent | Dennis H Crane OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
Product Code | JDI |
CFR Regulation Number | 888.3350 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-20 |
Decision Date | 1987-03-20 |