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510(k) K151661

Renovo Life Hard Carbon Coated Drill Bit by Renovo Life, LLC — Product Code HTW

K151661 is an FDA 510(k) premarket notification submitted by Renovo Life, LLC for the device "Renovo Life Hard Carbon Coated Drill Bit". The FDA issued a decision of Substantially Equivalent on January 15, 2016. The device falls under product code HTW (Bit, Drill), a Class I device regulated under 21 CFR 888.4540. Renovo Life, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2016
Date Received
June 19, 2015
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 Renovo Life, LLC

  • K161254 — Renovo Life Small Bone IM Nail System (November 7, 2016)

Other clearances for product code HTW

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

FDA data resources