The following data is part of a premarket notification filed by Osteo Ag with the FDA for Osteo Complete Pneumatic Drill-oscilair.
| Device ID | K913559 |
| 510k Number | K913559 |
| Device Name: | OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | OSTEO AG 208 WILSON BRIDGE RD. Greenwood, SC 29646 |
| Contact | Bryson, Jr. |
| Correspondent | Bryson, Jr. OSTEO AG 208 WILSON BRIDGE RD. Greenwood, SC 29646 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-11-07 |