The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Kls Martin Xternal Fixator.
| Device ID | K072764 |
| 510k Number | K072764 |
| Device Name: | KLS MARTIN XTERNAL FIXATOR |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | KLS MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Contact | Tom Faucett |
| Correspondent | Tom Faucett KLS MARTIN L.P. 11239 ST. JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-28 |
| Decision Date | 2007-12-20 |
| Summary: | summary |