The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Resorb-x G.
| Device ID | K121606 |
| 510k Number | K121606 |
| Device Name: | RESORB-X G |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Jennifer Damato KLS-MARTIN L.P. 11201 SAINT JOHNS INDUSTRIAL PARKWAY SOUTH Jacksonville, FL 32246 |
| Product Code | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-01 |
| Decision Date | 2013-01-17 |
| Summary: | summary |