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510(k) K933933

CEBOPLANE by Synvasive Technology, Inc. — Product Code HTZ

K933933 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "CEBOPLANE". The FDA issued a decision of Substantially Equivalent on April 15, 1994. The device falls under product code HTZ (Instrument, Cutting, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1994
Date Received
August 11, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cutting, Orthopedic
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
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)
  • K934336 — SPINALPLANE (March 10, 1995)
  • 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 HTZ

  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)
  • K870882 — 45 DEGREE SHAVER (March 23, 1987)
  • K853678 — KAMBIN SPINAL INSTRUMENT SET (September 24, 1985)
  • K850527 — ARTHROSCOPY SUCTION BIOPSY PUNCH (March 14, 1985)
  • K850423 — CONCEPT SUCTION SLEEVE (March 14, 1985)
  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K842774 — CODMAN SUCTION PUNCH-PRODUCT CODES (July 27, 1984)
  • K842111 — KOGAN ENDOSPECULUM 9-1/2 (June 19, 1984)
  • K841975 — ROSETTE KNIFE 4MM (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

FDA data resources