The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Alteon Monobloc Revision Stem.
| Device ID | K181532 |
| 510k Number | K181532 |
| Device Name: | Exactech Alteon Monobloc Revision Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Zach Sharrah |
| Correspondent | Zach Sharrah Exactech, Inc. 2320 NW 66th Court Gainesville, FL 32653 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-11 |
| Decision Date | 2018-09-04 |
| Summary: | summary |