The following data is part of a premarket notification filed by Arc Surgical Llc. with the FDA for Arc Surgical Resorbable Compression Screw System.
| Device ID | K043176 |
| 510k Number | K043176 |
| Device Name: | ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ARC SURGICAL LLC. 5885 NW CORNELIUS PASS ROAD SUITE 100 Hillsboro, OR 97124 |
| Contact | Ed Boehmer |
| Correspondent | Ed Boehmer ARC SURGICAL LLC. 5885 NW CORNELIUS PASS ROAD SUITE 100 Hillsboro, OR 97124 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-16 |
| Decision Date | 2005-06-17 |
| Summary: | summary |