The following data is part of a premarket notification filed by Bonafix Surgical And Dental Implants, Llc with the FDA for Orthofix Screw.
| Device ID | K113650 |
| 510k Number | K113650 |
| Device Name: | ORTHOFIX SCREW |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC 118 W. PRIVE CR. Delray Tezak, FL 33445 |
| Contact | Juan Tezak |
| Correspondent | Juan Tezak BONAFIX SURGICAL AND DENTAL IMPLANTS, LLC 118 W. PRIVE CR. Delray Tezak, FL 33445 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-12 |
| Decision Date | 2012-10-03 |
| Summary: | summary |