The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Hcl Acetabular Components.
| Device ID | K803192 |
| 510k Number | K803192 |
| Device Name: | HCL ACETABULAR COMPONENTS |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | OSTEONICS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-16 |
| Decision Date | 1981-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327101676 | K803192 | 000 |
| 07613327038415 | K803192 | 000 |
| 07613327038408 | K803192 | 000 |
| 07613327038392 | K803192 | 000 |
| 07613327038385 | K803192 | 000 |
| 07613327038378 | K803192 | 000 |
| 07613327038361 | K803192 | 000 |
| 07613327038354 | K803192 | 000 |
| 07613327032598 | K803192 | 000 |
| 07613327032581 | K803192 | 000 |
| 07613327032574 | K803192 | 000 |
| 07613327032567 | K803192 | 000 |
| 07613327032550 | K803192 | 000 |
| 07613327032543 | K803192 | 000 |
| 07613327038422 | K803192 | 000 |
| 07613327038439 | K803192 | 000 |
| 07613327039184 | K803192 | 000 |
| 07613327039177 | K803192 | 000 |
| 07613327038545 | K803192 | 000 |
| 07613327038538 | K803192 | 000 |
| 07613327038521 | K803192 | 000 |
| 07613327038514 | K803192 | 000 |
| 07613327038507 | K803192 | 000 |
| 07613327038491 | K803192 | 000 |
| 07613327038484 | K803192 | 000 |
| 07613327038477 | K803192 | 000 |
| 07613327038460 | K803192 | 000 |
| 07613327038453 | K803192 | 000 |
| 07613327038446 | K803192 | 000 |
| 07613327032536 | K803192 | 000 |