The following data is part of a premarket notification filed by Kls Martin Lp with the FDA for Kls Martin Cannulated Headless Screws.
| Device ID | K161259 |
| 510k Number | K161259 |
| Device Name: | KLS Martin Cannulated Headless Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | KLS MARTIN LP 11201 SAINT JOHNS INDUSTRIAL PARKWAY S Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Gary Moore KLS MARTIN LP 11201 SAINT JOHNS INDUSTRIAL PARKWAY S Jacksonville, FL 32246 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-04 |
| Decision Date | 2016-12-19 |
| Summary: | summary |