The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Crossfire System 12 Acetabular Inserts.
| Device ID | K993352 |
| 510k Number | K993352 |
| Device Name: | CROSSFIRE SYSTEM 12 ACETABULAR INSERTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Terry Sheridan Powell |
| Correspondent | Terry Sheridan Powell HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-05 |
| Decision Date | 1999-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327038781 | K993352 | 000 |
| 07613327038668 | K993352 | 000 |
| 07613327038651 | K993352 | 000 |
| 07613327038644 | K993352 | 000 |
| 07613327038637 | K993352 | 000 |
| 07613327038620 | K993352 | 000 |
| 07613327038613 | K993352 | 000 |
| 07613327038606 | K993352 | 000 |
| 07613327038590 | K993352 | 000 |
| 07613327038583 | K993352 | 000 |
| 07613327038675 | K993352 | 000 |
| 07613327038682 | K993352 | 000 |
| 07613327038774 | K993352 | 000 |
| 07613327038767 | K993352 | 000 |
| 07613327038750 | K993352 | 000 |
| 07613327038743 | K993352 | 000 |
| 07613327038736 | K993352 | 000 |
| 07613327038729 | K993352 | 000 |
| 07613327038712 | K993352 | 000 |
| 07613327038705 | K993352 | 000 |
| 07613327038699 | K993352 | 000 |
| 07613327038576 | K993352 | 000 |