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510(k) K831712

SURGICAL DRILL BITS by Medical Specialists IN Packaging — Product Code HTW

K831712 is an FDA 510(k) premarket notification submitted by Medical Specialists IN Packaging for the device "SURGICAL DRILL BITS". The FDA issued a decision of Substantially Equivalent on July 7, 1983. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. Medical Specialists IN Packaging has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1983
Date Received
May 27, 1983
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 Medical Specialists IN Packaging

  • K830901 — CONNECTOR 5 IN 1, T-CONNECTOR (April 6, 1983)

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)
  • K820226 — UNIVERSALL DRILL GUIDE (February 4, 1982)

FDA data resources