Osteotome Model Numbers 2500-228 & 2500-229
FDA 510(k) K903713 · Micro-Aire Surgical Instruments, Inc.
510(k) numberK903713
Submission
- Device name
- Osteotome Model Numbers 2500-228 & 2500-229
- Applicant
- Micro-Aire Surgical Instruments, Inc.
Valencia, CA, US - Received
- August 14, 1990
- Decision date
- September 14, 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
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 |
|---|---|---|
| K904949 | A.O. Synthes,Tap(Replacement)Various Model NumbersHSZ · Traditional | 11/26/1990SE |
| K903650 | Oscillating Saw Blades # SO-305,MO-305 and ZO-305HWE · Traditional | 09/14/1990SE |
| K902676 | Microguard, Orthopedic Pin ProtectorsLYT · Traditional | 09/14/1990SE |
| K903664 | Micro-Aire Wire Pass and Craniotome DrillHBE · Traditional | 09/13/1990SE |
| K901967 | Dendia Werk Burs and Cutting DiscsDZP · Traditional | 07/13/1990SE |
| K902168 | Arthroscopic Surgery Blades (Several Models)HRX · Traditional | 06/20/1990SE |
| K901735 | Arthroscopic Surgery Blades DY-3440, 3443, 3444HRX · Traditional | 06/20/1990SE |
| K900033 | Micro-Aire Powered Micro-Surgery InstrumentsGEY · Traditional | 02/13/1990SE |
| K900210 | Bone Harvester System & Osteotome System 2500HSZ · Traditional | 02/02/1990SE |
| K896280 | Micro-Aire Oscillating Saw Blade 202C-25, 202C-50GFA · Traditional | 11/22/1989SE |
Questions and answers
When was Osteotome Model Numbers 2500-228 & 2500-229 cleared by the FDA?
Osteotome Model Numbers 2500-228 & 2500-229 (K903713) received a 510(k) decision of Substantially Equivalent on September 14, 1990, 31 days after the submission was received.
What is the product code of K903713?
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.