The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Kls Martin Ips Distraction.
| Device ID | K220050 |
| 510k Number | K220050 |
| Device Name: | KLS Martin IPS Distraction |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | KLS Martin L.P. 11201 Saint Johns Industrial Parkway S Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Susan Leander KLS Martin L.P. 11201 Saint Johns Industrial Parkway S 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 | 2022-01-06 |
| Decision Date | 2022-08-11 |