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510(k) K972508

SURGICAL BURS AND SURGICAL DRILL BITS by Synvasive Technology, Inc. — Product Code HWE

K972508 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "SURGICAL BURS AND SURGICAL DRILL BITS". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And 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
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
July 3, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And 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)
  • 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)
  • 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 HWE

  • K143191 — IntelliSense Drill (February 20, 2015)
  • K102743 — ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES (January 20, 2011)
  • K063688 — SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE (January 16, 2007)
  • K050766 — EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEM (May 26, 2005)
  • K043310 — SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM (January 5, 2005)
  • K022744 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (September 18, 2002)
  • K012676 — REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS (February 4, 2002)
  • K012694 — REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS (February 4, 2002)
  • K990816 — AVCORE SYSTEM (September 24, 1999)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)

FDA data resources