The following data is part of a premarket notification filed by Kls Martin Lp with the FDA for Internal Distraction - Sterile.
| Device ID | K163315 |
| 510k Number | K163315 |
| Device Name: | Internal Distraction - Sterile |
| Classification | Cranial Distraction System |
| Applicant | KLS Martin LP 11201 Saint Johns Industrial Pkwy S Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS Martin LP 11201 Saint Johns Industrial Pkwy S 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 | 2016-11-23 |
| Decision Date | 2017-05-05 |
| Summary: | summary |