The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Rxg Distraction System.
| Device ID | K133304 |
| 510k Number | K133304 |
| Device Name: | RXG DISTRACTION SYSTEM |
| Classification | Plate, Bone |
| Applicant | KLS-MARTIN L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-28 |
| Decision Date | 2014-05-15 |
| Summary: | summary |