# K981459: Membrane Tack

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 14, 1998 after 82 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- 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) marketed bioresorbable membrane tack: named in the summary without a submission number

## Indications for use
The Membrane Tack is indicated for use as a means of membrane fixation in Guided Bone Regeneration (GBR) procedures.

Source page: https://510kreport.com/device/K981459
Methodology: https://510kreport.com/methodology