The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Centre-drive Drill-free Screw.
| Device ID | K971297 |
| 510k Number | K971297 |
| Device Name: | CENTRE-DRIVE DRILL-FREE SCREW |
| Classification | Plate, Fixation, Bone |
| Applicant | KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Contact | Mike Greene |
| Correspondent | Mike Greene KLS-MARTIN L.P. 11239-1 ST. JOHN'S IND. PKWY. SOUTH Jacksonville, FL 32246 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-08 |
| Decision Date | 1997-05-08 |