The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Micro Osteosynthesis System (1.0).
| Device ID | K944561 |
| 510k Number | K944561 |
| Device Name: | MICRO OSTEOSYNTHESIS SYSTEM (1.0) |
| Classification | Plate, Bone |
| Applicant | KLS-MARTIN L.P. 2550 M STREET, N.W. Washington, DC 20037 |
| Contact | Mark A Heller |
| Correspondent | Mark A Heller KLS-MARTIN L.P. 2550 M STREET, N.W. Washington, DC 20037 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-16 |
| Decision Date | 1994-10-18 |