Synvasive Technology, Inc.
Deer Field, IL, US
Synvasive Technology, Inc. appears in FDA device records in Deer Field, IL. FDA records list 10 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Synvasive Technology, Inc. between 1994 and 2011. The busiest year on record is 1994, with 4. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 2007 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093046 | ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES | ONN | Substantially Equivalent | |
| K070108 | ELIBRA DYNAMIC KNEE BALANCER | ONN | Substantially Equivalent | |
| K972508 | SURGICAL BURS AND SURGICAL DRILL BITS | HWE | Substantially Equivalent | |
| K961522 | KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN | HTY | Substantially Equivalent | |
| K950009 | POWERGRIP(TM) COMPRESSION FIXATION DEVICE | JDW | Substantially Equivalent | |
| K934336 | SPINALPLANE | HSZ | Substantially Equivalent for Some Indications | |
| K933933 | CEBOPLANE | HTZ | Substantially Equivalent | |
| K930573 | SYNVASIVE CERAMIC SUTTING BLOCK | LXI | Substantially Equivalent | |
| K932869 | ARTHROPLANE | HRX | Substantially Equivalent | |
| K931737 | HEDLEYL INTRAMEDULLARY PREPARATION BRUSH | HTZ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HRXArthroscope
- LXIGuide, Drill, Ligament
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
- ONNIntraoperative Orthopedic Joint Assessment Aid
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1676-2020 | 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 | Mislabeled: Actual blade width is 19 mm but the label indicates a width of 25 mm. | Class II | Terminated | |
| Z-0466-2016 | 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 Plastic Surgery: The oscillating surgical saw blade is intended for use with powered equipment to resect bone and/or cartilage in orthopedic procedures | Two lots of oscillating saw blades incorrectly identify the blade cutting width as 25mm instead of the correct specification of 19mm. | Class II | Terminated | |
| Z-1115-2013 | 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 sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement. | Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System. | Class II | Terminated | |
| Z-1127-2013 | 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 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane. | Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain