The following data is part of a premarket notification filed by Infix Medical Llc with the FDA for Infix Cannulated Screw System.
| Device ID | K142057 |
| 510k Number | K142057 |
| Device Name: | INFIX CANNULATED SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | INFIX MEDICAL LLC 69 Baybridge Dr Suite M Gulf Breeze, FL 32561 |
| Contact | James C Holley |
| Correspondent | James C Holley INFIX MEDICAL LLC 69 Baybridge Dr Suite M Gulf Breeze, FL 32561 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-29 |
| Decision Date | 2015-01-13 |
| Summary: | summary |