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510(k) K990816

AVCORE SYSTEM by Modular Cutting Systems, Inc. — Product Code HWE

K990816 is an FDA 510(k) premarket notification submitted by Modular Cutting Systems, Inc. for the device "AVCORE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 24, 1999. 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. Modular Cutting Systems, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1999
Date Received
March 11, 1999
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 Modular Cutting Systems, Inc.

  • K991037 — EUCLID REDUCTION AND GUIDANCE SYSTEM (June 23, 1999)

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)
  • K973736 — AESCULAP HILAN MOTOR SYSTEM (December 29, 1997)
  • K973560 — BONE GRAFT HARVESTER (November 12, 1997)

FDA data resources