The following data is part of a premarket notification filed by Kls Martin L.p. with the FDA for Rxg Distraction System.
| Device ID | K150771 |
| 510k Number | K150771 |
| Device Name: | RxG Distraction System |
| Classification | Cranial Distraction System |
| Applicant | KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Gary Moore KLS MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | PBJ |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-24 |
| Decision Date | 2015-08-27 |
| Summary: | summary |