The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Alteon Neck Preserving Femoral Stem, Standard Offset, Size 6-7; Alteon Neck Preserving Femoral Stem, Extended Offset.
| Device ID | K141821 |
| 510k Number | K141821 |
| Device Name: | ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7; ALTEON NECK PRESERVING FEMORAL STEM, EXTENDED OFFSET |
| 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 | Thomas Mcnamara |
| Correspondent | Thomas Mcnamara EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LZO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LPH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-08-28 |
| Summary: | summary |