# K050628: Anspach Coupler

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Apr 7, 2005 after 27 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- 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) Other Anspach Nosepiece Attachments: named in the summary without a submission number

## Indications for use
The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for use by trained medical personnel as an interface coupling device, to permit attachment to and operation of the Medtronic, Midas Rex "Legend" Bone Mill (BM100) and Disposable Bowl (BM200) with an Anspach motor.

Source page: https://510kreport.com/device/K050628
Methodology: https://510kreport.com/methodology