The following data is part of a premarket notification filed by Anulex Technologies, Inc with the FDA for Micro/mini N-pk(h) Bone Anchor.
| Device ID | K121356 |
| 510k Number | K121356 |
| Device Name: | MICRO/MINI N-PK(H) BONE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Contact | Rachel Kennedy |
| Correspondent | Rachel Kennedy ANULEX TECHNOLOGIES, INC 5600 ROWLAND ROAD, STE 280 Minnetonka, MN 55343 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-04 |
| Decision Date | 2012-11-09 |
| Summary: | summary |