The following data is part of a premarket notification filed by Kls Martin Lp with the FDA for Level One Hand Plating System.
| Device ID | K170124 |
| 510k Number | K170124 |
| Device Name: | Level One Hand Plating System |
| Classification | Plate, 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 PKWY S Jacksonville, FL 32246 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-13 |
| Decision Date | 2017-03-09 |
| Summary: | summary |