Synvasive Technology, Inc.
Synvasive Technology, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2011, with 4 FDA device recalls on record.
Top product codes for Synvasive Technology, Inc.
FDA recalls by Synvasive Technology, Inc.
- 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
- 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
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Synvasive Technology, Inc.
- K093046 — ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
- K070108 — ELIBRA DYNAMIC KNEE BALANCER
- K972508 — SURGICAL BURS AND SURGICAL DRILL BITS
- K961522 — KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
- K950009 — POWERGRIP(TM) COMPRESSION FIXATION DEVICE
- K934336 — SPINALPLANE
- K933933 — CEBOPLANE
- K930573 — SYNVASIVE CERAMIC SUTTING BLOCK
- K932869 — ARTHROPLANE
- K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH
Data sourced from openFDA. This site is unofficial and independent of the FDA.