The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Hammertech Fixation System.
| Device ID | K161449 |
| 510k Number | K161449 |
| Device Name: | HammerTech Fixation System |
| Classification | Screw, Fixation, Bone |
| Applicant | Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212 |
| Contact | Adam Cundiff |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-25 |
| Decision Date | 2016-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852164007209 | K161449 | 000 |
| 00852164007018 | K161449 | 000 |
| 00852164007025 | K161449 | 000 |
| 00852164007032 | K161449 | 000 |
| 00852164007148 | K161449 | 000 |
| 00852164007155 | K161449 | 000 |
| 00852164007162 | K161449 | 000 |
| 00852164007179 | K161449 | 000 |
| 00852164007186 | K161449 | 000 |
| 00852164007193 | K161449 | 000 |
| 00852164007001 | K161449 | 000 |