Bone Rasps
FDA 510(k) K905187 · Micro Surgical Instruments Corp.
510(k) numberK905187
Submission
- Device name
- Bone Rasps
- Applicant
- Micro Surgical Instruments Corp.
Valencia, CA, US - Received
- November 19, 1990
- Decision date
- December 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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| 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 |
|---|---|---|
| K931395 | Series 5000 Battery Powered Instrument SystemKIJ · Traditional | 01/28/1994SE |
| K932492 | Implantology Module, Model 2175JEY · Traditional | 10/05/1993SE |
| K930205 | Electric Wire Driver, Model 2640EHXJ · Traditional | 08/02/1993SE |
| K914998 | Microaire(R) Facial Bone Plating SystemHRS · Traditional | 06/02/1992SE |
| K915139 | Model 2250-000 Zimmer Style Sagittal Saw ModuleHSZ · Traditional | 02/05/1992SE |
| K914346 | Drill Modules Models 2116/2117ERL · Traditional | 11/27/1991SE |
| K913369 | Micro-Aire Model 2060GEY · Traditional | 11/01/1991SE |
| K913266 | Micro-Aire Model 2050E/ELEC Handpiece/TrottlelessGEY · Traditional | 10/21/1991SE |
| K910175 | Fixation Devices and Bone PlateHRS · Traditional | 06/21/1991SN |
| K905383 | 2710-000 Oscillating Saw, General AssemblyGEY · Traditional | 06/18/1991SE |
Questions and answers
When was Bone Rasps cleared by the FDA?
Bone Rasps (K905187) received a 510(k) decision of Substantially Equivalent on December 19, 1990, 30 days after the submission was received.
What is the product code of K905187?
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.