# K972906: Medtronic Twist Lock Anchor (Partnumber 103953/3550TLA)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Feb 6, 1998 after 184 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Medtronic Lead Anchor Accessory Model 3550-01 (current silicone rubber anchor): named in the summary without a submission number

## Most influential descendants
- K013063: Grip Lock Anchor, Model 411374 (2001), 0 descendants of its own

## Indications for use
The Medtronic Twist Lock Anchor, Part Number 103953 or Model 3550TLA, is indicated as an alternate anchor accessory for use with Spinal Cord Stimulation (SCS) Systems for the treatment of chronic intractable pain of the trunk or limbs. The Twist Lock Anchor is only for use with coiled conductor Medtronic Neurological Spinal Cord Stimulation leads with an outside diameter of 1.27 mm. All other uses are contraindicated.

Source page: https://510kreport.com/device/K972906
Methodology: https://510kreport.com/methodology