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510(k) K921131

CKS OSCILLATING SAW BLADE by Techmedica, Inc. — Product Code HWE

K921131 is an FDA 510(k) premarket notification submitted by Techmedica, Inc. for the device "CKS OSCILLATING SAW BLADE". The FDA issued a decision of Substantially Equivalent on June 8, 1992. 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. Techmedica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1992
Date Received
March 10, 1992
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 Techmedica, Inc.

  • K933935 — CKS POROUS COATED FEMORAL COMPONENT (October 11, 1994)
  • K932017 — TECHMEDICA CONTINUUM HIP WITH HA COATING (September 1, 1994)
  • K931929 — TECHMEDICA CONTINUUM HIP SYSTEM (March 29, 1994)
  • K926387 — TECHMEDICA STANDARD CEMENTED HIP SYSTEM (February 1, 1994)
  • K925420 — TECHMEDICA STANDARD BIPOLAR SYSTEM (September 28, 1993)
  • K923808 — MULLER STRAIGHT STEM FEMORAL PROSTHESIS (July 27, 1993)
  • K926579 — TECHMEDICA 6.5MM SELF-TAPPING CANCELLOUS BONE SCRE (April 6, 1993)
  • K911058 — TECHMEDICA CAD/CAM CUSTOM HIP (February 23, 1993)
  • K925181 — TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP (February 5, 1993)
  • K920080 — CONTINUUM KNEE SYSTEM (September 1, 1992)

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