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510(k) K934336

SPINALPLANE by Synvasive Technology, Inc. — Product Code HSZ

K934336 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "SPINALPLANE". The FDA issued a decision of SN on March 10, 1995. The device falls under product code HSZ (Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 10, 1995
Date Received
September 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Synvasive Technology, Inc.

  • 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)
  • 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)

Other clearances for product code HSZ

  • K991588 — EMS SWISS ORTHOCLAST (July 21, 1999)
  • K972860 — CURVTEK TSR SYSTEM (October 31, 1997)
  • K970345 — ALIGNMENT INSTRUMENT (April 29, 1997)
  • K955084 — ASPACH 65,000 (MODIFICATION) (January 17, 1996)
  • K954080 — SODEM HIGH SPEED SYSTEM (October 16, 1995)
  • K944590 — ETHICON DRILL BIT AND DRILL GUIDE (May 11, 1995)
  • K940276 — FILTER, DIFFUSER (November 16, 1994)
  • K942760 — PNEUMATIC WIRE TENSIONER (September 6, 1994)
  • K941681 — ARTHREX CIRCULAR HARVESTING SAW (August 25, 1994)
  • K935367 — TAVA WIRE-DRIVER (April 21, 1994)

FDA data resources