The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Alteon 6.5mm Bone Screws.
| Device ID | K141797 |
| 510k Number | K141797 |
| Device Name: | ALTEON 6.5MM BONE SCREWS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, 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 | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2014-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862241504 | K141797 | 000 |
| 10885862010551 | K141797 | 000 |
| 10885862010544 | K141797 | 000 |
| 10885862010537 | K141797 | 000 |
| 10885862553041 | K141797 | 000 |
| 10885862553034 | K141797 | 000 |
| 10885862173089 | K141797 | 000 |
| 10885862173065 | K141797 | 000 |
| 10885862173041 | K141797 | 000 |
| 10885862010681 | K141797 | 000 |
| 10885862010667 | K141797 | 000 |
| 10885862010636 | K141797 | 000 |
| 10885862010643 | K141797 | 000 |
| 10885862013750 | K141797 | 000 |
| 10885862013743 | K141797 | 000 |
| 10885862010568 | K141797 | 000 |
| 10885862010575 | K141797 | 000 |
| 10885862241498 | K141797 | 000 |
| 10885862241481 | K141797 | 000 |
| 10885862038272 | K141797 | 000 |
| 10885862013736 | K141797 | 000 |
| 10885862010704 | K141797 | 000 |
| 10885862010698 | K141797 | 000 |
| 10885862010629 | K141797 | 000 |
| 10885862010612 | K141797 | 000 |
| 10885862553003 | K141797 | 000 |
| 10885862552976 | K141797 | 000 |
| 10885862552952 | K141797 | 000 |
| 10885862552938 | K141797 | 000 |
| 10885862241528 | K141797 | 000 |
| 10885862010582 | K141797 | 000 |
| 10885862241535 | K141797 | 000 |