The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro - Infinity Plate Anchor System.
| Device ID | K132510 |
| 510k Number | K132510 |
| Device Name: | BIOPRO - INFINITY PLATE ANCHOR SYSTEM |
| Classification | Washer, Bolt Nut |
| Applicant | BIOPRO, INC. 3150 E. 200TH ST Prior Lake, MN 55372 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott BIOPRO, INC. 3150 E. 200TH ST Prior Lake, MN 55372 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-12 |
| Decision Date | 2013-10-24 |
| Summary: | summary |