The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Alteon Monobloc Revision Stem.
| Device ID | K150066 |
| 510k Number | K150066 |
| Device Name: | Exactech Alteon Monobloc Revision Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Patrick Hughes |
| Correspondent | Patrick Hughes EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-13 |
| Decision Date | 2015-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862298706 | K150066 | 000 |
| 10885862284501 | K150066 | 000 |
| 10885862284488 | K150066 | 000 |
| 10885862284471 | K150066 | 000 |
| 10885862284464 | K150066 | 000 |
| 10885862284457 | K150066 | 000 |
| 10885862284440 | K150066 | 000 |
| 10885862284433 | K150066 | 000 |
| 10885862284426 | K150066 | 000 |
| 10885862284419 | K150066 | 000 |
| 10885862284402 | K150066 | 000 |
| 10885862284396 | K150066 | 000 |
| 10885862284389 | K150066 | 000 |
| 10885862284372 | K150066 | 000 |
| 10885862284365 | K150066 | 000 |
| 10885862284518 | K150066 | 000 |
| 10885862284525 | K150066 | 000 |
| 10885862284532 | K150066 | 000 |
| 10885862298683 | K150066 | 000 |
| 10885862284495 | K150066 | 000 |
| 10885862515865 | K150066 | 000 |
| 10885862515858 | K150066 | 000 |
| 10885862284631 | K150066 | 000 |
| 10885862284624 | K150066 | 000 |
| 10885862284617 | K150066 | 000 |
| 10885862284600 | K150066 | 000 |
| 10885862284594 | K150066 | 000 |
| 10885862284587 | K150066 | 000 |
| 10885862284570 | K150066 | 000 |
| 10885862284563 | K150066 | 000 |
| 10885862284556 | K150066 | 000 |
| 10885862284549 | K150066 | 000 |
| 10885862284358 | K150066 | 000 |