Spinalplane
FDA 510(k) K934336 · Synvasive Technology, Inc.
510(k) numberK934336
Submission
- Device name
- Spinalplane
- Applicant
- Synvasive Technology, Inc.
Rancho Cordova, CA, US - Received
- September 7, 1993
- Decision date
- March 10, 1995
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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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|---|---|---|---|
| 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 |
| 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 |
| K935367 | Tava Wire-DriverHSZ · Traditional | Tava Surgical Instruments | 04/21/1994SE |
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| K093046 | Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX(5 Models, Different SizesONN · Traditional | 03/22/2011SE |
| K070108 | Elibra Dynamic Knee BalancerONN · Traditional | 04/04/2007SE |
| K972508 | Surgical Burs and Surgical Drill BitsHWE · Traditional | 08/26/1997SE |
| K961522 | Kirschner Wire (K-Wire) and Steinmann PinHTY · Traditional | 09/23/1996SE |
| K950009 | Powergrip(Tm) Compression Fixation DeviceJDW · Traditional | 08/18/1995SE |
| K933933 | CeboplaneHTZ · Traditional | 04/15/1994SE |
| K930573 | Synvasive Ceramic Sutting BlockLXI · Traditional | 04/07/1994SE |
| K932869 | ArthroplaneHRX · Traditional | 03/25/1994SE |
| K931737 | Hedleyl Intramedullary Preparation BrushHTZ · Traditional | 01/07/1994SE |
Questions and answers
When was Spinalplane cleared by the FDA?
Spinalplane (K934336) received a 510(k) decision of Substantially Equivalent for Some Indications on March 10, 1995, 549 days after the submission was received.
What is the product code of K934336?
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.