The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axyaloop Nonabsorbable Bone Anchor.
| Device ID | K060970 |
| 510k Number | K060970 |
| Device Name: | AXYALOOP NONABSORBABLE BONE ANCHOR |
| Classification | Staple, Fixation, Bone |
| Applicant | AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard Schrayer |
| Correspondent | Howard Schrayer AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | JDR |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-07 |
| Decision Date | 2006-07-05 |
| Summary: | summary |