Medical Device Manufacturer · US , Rancho Cordova , CA

Synvasive Technology, Inc.

10 submissions · 9 cleared · Since 1994
10
Total
9
Cleared
0
Denied

Synvasive Technology, Inc. — FDA 510(k) Submissions

Synvasive Technology, Inc. has submitted 10 FDA 510(k) premarket notifications since 1994, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Intraoperative Orthopedic Joint Assessment Aid, Instrument, Cutting, Orthopedic, Pin, Fixation, Threaded, Pin, Fixation, Smooth, Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES
K093046 · ONN Intraoperative Orthopedic... · Orthopedic
Mar 2011 538d
ELIBRA DYNAMIC KNEE BALANCER
K070108 · ONN Intraoperative Orthopedic... · Orthopedic
Apr 2007 83d
SURGICAL BURS AND SURGICAL DRILL BITS
K972508 · HWE Instrument, Surgical,... · Orthopedic
Aug 1997 54d
KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN
K961522 · HTY Pin, Fixation, Smooth · Orthopedic
Sep 1996 154d
POWERGRIP(TM) COMPRESSION FIXATION DEVICE
K950009 · JDW Pin, Fixation, Threaded · Orthopedic
Aug 1995 227d
SPINALPLANE
K934336 · HSZ Instrument, Surgical,... · Orthopedic
Mar 1995 549d
CEBOPLANE
K933933 · HTZ Instrument, Cutting,... · General & Plastic Surgery
Apr 1994 247d
SYNVASIVE CERAMIC SUTTING BLOCK
K930573 · LXI Guide, Drill, Ligament · Orthopedic
Apr 1994 427d
ARTHROPLANE
K932869 · HRX Arthroscope · Orthopedic
Mar 1994 284d
HEDLEYL INTRAMEDULLARY PREPARATION BRUSH
K931737 · HTZ Instrument, Cutting,... · General & Plastic Surgery
Jan 1994 275d
Filters