# K151661: Renovo Life Hard Carbon Coated Drill Bit

- Pathway: 510(k) (Traditional)
- Applicant: Renovo Life, LLC
- Decided: Jan 15, 2016 after 210 days
- Product code: HTW (Bit, Drill)
- Device class: 1
- Regulation: 21 CFR 888.4540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mahe Surgical Drill Bits: named in the summary without a submission number

## Indications for use
The Renovo Life Hard Carbon Coated Drill Bit is used to cut bone prior to insertion of bone screws or guide pins.

Source page: https://510kreport.com/device/K151661
Methodology: https://510kreport.com/methodology