The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Modular Replacement System Cemented Stems.
| Device ID | K040749 |
| 510k Number | K040749 |
| Device Name: | MODULAR REPLACEMENT SYSTEM CEMENTED STEMS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-23 |
| Decision Date | 2004-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327049787 | K040749 | 000 |
| 07613327048452 | K040749 | 000 |
| 07613327048445 | K040749 | 000 |
| 07613327048438 | K040749 | 000 |
| 07613327048421 | K040749 | 000 |
| 07613327048414 | K040749 | 000 |
| 07613327048384 | K040749 | 000 |
| 07613327048377 | K040749 | 000 |
| 07613327048360 | K040749 | 000 |
| 07613327048353 | K040749 | 000 |
| 07613327048346 | K040749 | 000 |
| 07613327048339 | K040749 | 000 |
| 07613327048322 | K040749 | 000 |
| 07613327048315 | K040749 | 000 |
| 07613327048308 | K040749 | 000 |
| 07613327048292 | K040749 | 000 |
| 07613327048285 | K040749 | 000 |
| 07613327048469 | K040749 | 000 |
| 07613327048476 | K040749 | 000 |
| 07613327049374 | K040749 | 000 |
| 07613327049367 | K040749 | 000 |
| 07613327048612 | K040749 | 000 |
| 07613327048605 | K040749 | 000 |
| 07613327048599 | K040749 | 000 |
| 07613327048582 | K040749 | 000 |
| 07613327048575 | K040749 | 000 |
| 07613327048568 | K040749 | 000 |
| 07613327048551 | K040749 | 000 |
| 07613327048544 | K040749 | 000 |
| 07613327048537 | K040749 | 000 |
| 07613327048520 | K040749 | 000 |
| 07613327048513 | K040749 | 000 |
| 07613327048506 | K040749 | 000 |
| 07613327048490 | K040749 | 000 |
| 07613327048483 | K040749 | 000 |
| 07613327048278 | K040749 | 000 |