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510(k) K760236

BUR, SURGICAL CARBIDE by Cutter Laboratories, Inc. — Product Code HTT

K760236 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "BUR, SURGICAL CARBIDE". The FDA issued a decision of Substantially Equivalent on July 26, 1976. The device falls under product code HTT (Burr, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1976
Date Received
July 15, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burr, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)

Other clearances for product code HTT

  • K862529 — HALL STERILE BUR (July 15, 1986)
  • K821695 — MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMER (July 20, 1982)
  • K802598 — CARBIDE CUTTING INSTRUMENT/INTRAARTICU (November 19, 1980)

FDA data resources