The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Sonicweld Rx (resorb-x).
| Device ID | K080862 |
| 510k Number | K080862 |
| Device Name: | SONICWELD RX (RESORB-X) |
| Classification | Plate, Bone |
| Applicant | KLS-MARTIN L.P. 11239 ST. JOHNS IND PKWY SOUTH Jacksonville, FL 32246 |
| Contact | Tom Faucett |
| Correspondent | Tom Faucett KLS-MARTIN L.P. 11239 ST. JOHNS IND PKWY SOUTH 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 | 2008-03-27 |
| Decision Date | 2008-07-21 |
| Summary: | summary |