# K081240: Tiger Discectomy Device

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Devices, LLC
- Decided: Feb 27, 2009 after 302 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971342 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971342: Disk Whisk Cutting Device (Conical, Elliptical and Ball Head), Disk Whisk, Inc. (1997) Summary page 1.
- K032891: TRANS1 Trans-Sacral Spinal Access and Preparation Kit, Trans1, Inc. (2004) Summary page 1.

## Indications for use
The Tiger Discectomy Device is indicated for use in endoscopic and non-endoscopic spinal procedures to assist in the removal of fibrous disc material between the T12 to S1 spinal segments.

Source page: https://510kreport.com/device/K081240
Methodology: https://510kreport.com/methodology