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510(k) K820226

UNIVERSALL DRILL GUIDE by Ortho Pared Instruments, Inc. — Product Code HTW

K820226 is an FDA 510(k) premarket notification submitted by Ortho Pared Instruments, Inc. for the device "UNIVERSALL DRILL GUIDE". The FDA issued a decision of Substantially Equivalent on February 4, 1982. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. Ortho Pared Instruments, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
January 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bit, Drill
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Ortho Pared Instruments, Inc.

  • K831772 — GUILLOTINE BLADE (July 7, 1983)
  • K820225 — MENISCUS EXTRACTOR (February 4, 1982)
  • K812566 — UNIVERSAL SUTURE PASSER (November 10, 1981)

Other clearances for product code HTW

  • K151661 — Renovo Life Hard Carbon Coated Drill Bit (January 15, 2016)
  • K942906 — AGEE-WRISTJACK PRE-DRILL KIT (December 22, 1994)
  • K930339 — REAMER BIT (August 6, 1993)
  • K915692 — CANNULATED DRILL BIT (January 16, 1992)
  • K892903 — MITEK ANCHOR DRILL (October 6, 1989)
  • K870217 — FEMORAL CEMENT REMOVAL INSTRUMENTS (February 6, 1987)
  • K863147 — GLENOID DRILL (September 5, 1986)
  • K841629 — DRILL BIT (August 27, 1984)
  • K834229 — BONE PLUGGING TOOL (January 10, 1984)
  • K831712 — SURGICAL DRILL BITS (July 7, 1983)

FDA data resources