# K972508: Surgical Burs and Surgical Drill Bits

- Pathway: 510(k) (Traditional)
- Applicant: Synvasive Technology, Inc.
- Decided: Aug 26, 1997 after 54 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- 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) DePuy standard surgical burs and surgical drill bits: named in the summary without a submission number
- (no number) MicroAire standard surgical burs and surgical drill bits: named in the summary without a submission number
- (no number) Synthes standard surgical burs and surgical drill bits: named in the summary without a submission number
- (no number) Zimmer standard surgical burs and surgical drill bits: named in the summary without a submission number

## Indications for use
Indications for use of the surgical bur and surgical drill bit devices are situations in surgical procedures where bone, hard tissue, or soft tissue is drilled, reamed, sculpted, augmented, reduced, replaced, or removed.

Source page: https://510kreport.com/device/K972508
Methodology: https://510kreport.com/methodology