Synvasive Technology Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 10
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1676-2020 | Class II | ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in or | July 27, 2018 |
| Z-0466-2016 | Class II | Zimmer Oscillating Flat - TS ST Hub; 75mm x 19mm x 1.00/1.27mm; Synvasive Part No. 11-4770: Pa | December 8, 2015 |
| Z-1115-2013 | Class II | Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) | April 2, 2013 |
| Z-1127-2013 | Class II | The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker Syste | March 14, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | March 22, 2011 |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | April 4, 2007 |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | August 26, 1997 |
| K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | September 23, 1996 |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | August 18, 1995 |
| K934336 | SPINALPLANE | March 10, 1995 |
| K933933 | CEBOPLANE | April 15, 1994 |
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | April 7, 1994 |
| K932869 | ARTHROPLANE | March 25, 1994 |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | January 7, 1994 |