# K974025: Anspach Shielded Attachment

- Pathway: 510(k) (Traditional)
- Applicant: The Anspach Effort, Inc.
- Decided: Jul 6, 1998 after 256 days
- Product code: GFF (Bur, Surgical, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4820
- Recalls of this device: 17 (0 Class I)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 6, 2016 · Class II · Z-1989-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1966-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1960-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1981-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1962-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1982-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1984-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1983-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1940-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1961-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1959-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Oct 6, 2016 · Class II · Z-1978-2017: Supplied Directions for Use (DFU) did not contain a recommended service interval.
- Sep 19, 2011 · Class II · Z-2077-2012: Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is
- Mar 31, 2011 · Class II · Z-0829-2014: Cutter was longer than was stated on the label
- Mar 31, 2011 · Class II · Z-0830-2014: Cutter was longer than was stated on the label
- Mar 17, 2011 · Not classified · Z-3202-2011: The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D
- Mar 17, 2011 · Not classified · Z-3203-2011: The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D

## Indications for use
Cutting and Shaping Bone.

Source page: https://510kreport.com/device/K974025
Methodology: https://510kreport.com/methodology