The following data is part of a premarket notification filed by Arc Surgical Llc. with the FDA for Arc Surgical Biotrak Pin System.
| Device ID | K071616 |
| 510k Number | K071616 |
| Device Name: | ARC SURGICAL BIOTRAK PIN SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | ARC SURGICAL LLC. 21300 NW JACOBSON RD. Hillsboro, OR 97124 |
| Contact | Ed Boehmer |
| Correspondent | Ed Boehmer ARC SURGICAL LLC. 21300 NW JACOBSON RD. Hillsboro, OR 97124 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-13 |
| Decision Date | 2007-12-19 |
| Summary: | summary |