The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls Martin 3dx External Distraction System.
| Device ID | K034027 |
| 510k Number | K034027 |
| Device Name: | KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. 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 | 2003-12-29 |
| Decision Date | 2004-02-27 |
| Summary: | summary |