The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Secure-fit Ad-ha Acetabular Component System.
| Device ID | K942900 |
| 510k Number | K942900 |
| Device Name: | OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Robert A Koch |
| Correspondent | Robert A Koch OSTEONICS CORP. 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-20 |
| Decision Date | 1995-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327038217 | K942900 | 000 |
| 07613327020373 | K942900 | 000 |
| 07613327020366 | K942900 | 000 |
| 07613327020359 | K942900 | 000 |
| 07613327020342 | K942900 | 000 |
| 07613327020335 | K942900 | 000 |
| 07613327020328 | K942900 | 000 |
| 07613327020311 | K942900 | 000 |
| 07613327020304 | K942900 | 000 |
| 07613327020298 | K942900 | 000 |
| 07613327020281 | K942900 | 000 |
| 07613327020274 | K942900 | 000 |
| 07613327020267 | K942900 | 000 |
| 07613327020250 | K942900 | 000 |
| 07613327020243 | K942900 | 000 |
| 07613327020236 | K942900 | 000 |
| 07613327020380 | K942900 | 000 |
| 07613327020397 | K942900 | 000 |
| 07613327020540 | K942900 | 000 |
| 07613327020533 | K942900 | 000 |
| 07613327020526 | K942900 | 000 |
| 07613327020519 | K942900 | 000 |
| 07613327020502 | K942900 | 000 |
| 07613327020496 | K942900 | 000 |
| 07613327020489 | K942900 | 000 |
| 07613327020472 | K942900 | 000 |
| 07613327020465 | K942900 | 000 |
| 07613327020458 | K942900 | 000 |
| 07613327020441 | K942900 | 000 |
| 07613327020434 | K942900 | 000 |
| 07613327020427 | K942900 | 000 |
| 07613327020410 | K942900 | 000 |
| 07613327020403 | K942900 | 000 |
| 07613327020229 | K942900 | 000 |