Company ยท US
Synvasive Technology, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2011. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 3 |
| HTZ | Instrument, Cutting, Orthopedic | 2 |
| ONN | Intraoperative Orthopedic Joint Assessment Aid | 2 |
| HRX | Arthroscope | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 |
| HTY | Pin, Fixation, Smooth | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| LXI | Guide, Drill, Ligament | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 22, 2011 | K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES Synvasive Technology, Inc. | ONN |
| Apr 4, 2007 | K070108 | ELIBRA DYNAMIC KNEE BALANCER Synvasive Technology, Inc. | ONN |
| Aug 26, 1997 | K972508 | SURGICAL BURS AND SURGICAL DRILL BITS Synvasive Technology, Inc. | HWE |
| Sep 23, 1996 | K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN Synvasive Technology, Inc. | HTY |
| Aug 18, 1995 | K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE Synvasive Technology, Inc. | JDW |
| Mar 10, 1995 | K934336 | SPINALPLANE Synvasive Technology, Inc. | HSZ |
| Apr 15, 1994 | K933933 | CEBOPLANE Synvasive Technology, Inc. | HTZ |
| Apr 7, 1994 | K930573 | SYNVASIVE CERAMIC SUTTING BLOCK Synvasive Technology, Inc. | LXI |
| Mar 25, 1994 | K932869 | ARTHROPLANE Synvasive Technology, Inc. | HRX |
| Jan 7, 1994 | K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH Synvasive Technology, Inc. | HTZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2018 | Synvasive Technology Inc ZIMMER Oscillating Saw Blade -Cutting 75mm x 19mm x 1.00/1.27mm.intended for bone or cartilage in orthopedic procedures.
Manufactured By:
Synvasive Technology, Inc., a Subsidiary of Zimmer Terminated |
GFA | None listed |
| Dec 8, 2015 | Synvasive Technology Inc Zimmer Oscillating Flat - TS ST Hub;
75mm x 19mm x 1.00/1.27mm;
Synvasive Part No. 11-4770:
Part No. 19075127YT1;
Lot No. 45104 and 43054
Description: STRYK_76542K_19X75X1.27T
General and Plasti Terminated |
GFA | None listed |
| Apr 17, 2013 | Synvasive Technology Inc The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED
For use with Stryker System 5, System 4, System 2000 and EDH.
Product Usage: For use with Stryker System 5, System 4, System Terminated |
HSD | K911902 |
| Apr 15, 2013 | Synvasive Technology Inc Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA
Reciprocating saw blade: A ste Terminated |
GFA | None listed |