Osteo Complete Pneumatic Drill-Oscilair
FDA 510(k) K913559 · Osteo AG
510(k) numberK913559
Submission
- Device name
- Osteo Complete Pneumatic Drill-Oscilair
- Applicant
- Osteo AG
Greenwood, SC, US - Received
- August 9, 1991
- Decision date
- November 7, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991588 | EMS Swiss OrthoclastHSZ · Traditional | (Ems Sa) Electro Medical Systems | 07/21/1999SE |
| K972860 | Curvtek TSR SystemHSZ · Traditional | Biolectron, Inc. | 10/31/1997SE |
| K970345 | Alignment InstrumentHSZ · Traditional | Richard Wolf Medical Instruments Corp. | 04/29/1997SE |
| K955084 | Aspach 65,000 (Modification)HSZ · Traditional | The Anspach Effort, Inc. | 01/17/1996SE |
| K954080 | Sodem High Speed SystemHSZ · Traditional | Sodem Diffusion SA | 10/16/1995SE |
| K944590 | Ethicon Drill Bit and Drill GuideHSZ · Traditional | ETHICON, Inc. | 05/11/1995SE |
| K934336 | SpinalplaneHSZ · Traditional | Synvasive Technology, Inc. | 03/10/1995SN |
| K940276 | Filter, DiffuserHSZ · Traditional | Anspach Mfg., Inc. | 11/16/1994SE |
| K942760 | Pneumatic Wire TensionerHSZ · Traditional | Smith & Nephew Richards, Inc. | 09/06/1994SE |
| K941681 | Arthrex Circular Harvesting SawHSZ · Traditional | Arthrex, Inc. | 08/25/1994SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K933340 | Osteo Interlocking-Compression NailHSB · Traditional | 06/30/1994SE |
| K922196 | Osteo Tibia NailHSB · Traditional | 07/23/1992SE |
| K922195 | Osteo Femoral NailHSB · Traditional | 07/23/1992SE |
| K922194 | Osteo Steinmann PinHTY · Traditional | 07/23/1992SE |
| K922193 | Osteo Kirschner WireHTY · Traditional | 07/23/1992SE |
| K920149 | Osteo Ex-Fi-ReJEC · Traditional | 04/09/1992SE |
| K920037 | Osteo Compression Hip ScrewHRC · Traditional | 03/11/1992SE |
| K914374 | Osteo Cerclage WireJDQ · Traditional | 12/30/1991SE |
Questions and answers
When was Osteo Complete Pneumatic Drill-Oscilair cleared by the FDA?
Osteo Complete Pneumatic Drill-Oscilair (K913559) received a 510(k) decision of Substantially Equivalent on November 7, 1991, 90 days after the submission was received.
What is the product code of K913559?
The FDA product code is HSZ – Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment, a Class I (low risk) device regulated under 21 CFR 878.4820.