The following data is part of a premarket notification filed by Biopro, Inc. with the FDA for Biopro Kwick-wire Universal Screw System.
| Device ID | K130298 |
| 510k Number | K130298 |
| Device Name: | BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM |
| Classification | Pin, Fixation, Threaded |
| 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 | JDW |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-07 |
| Decision Date | 2013-06-18 |
| Summary: | summary |