# K113352: Transcorp Spinal Access System

- Pathway: 510(k) (Traditional)
- Applicant: Transcorp, Inc.
- Decided: Apr 16, 2012 after 154 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 K032891 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032891: TRANS1 Trans-Sacral Spinal Access and Preparation Kit, Trans1, Inc. (2004) Summary page 1.

## Indications for use
The Transcorp Spinal Access System is indicated for minimally invasive visualization and access to the anterior spine for assisting in various surgical procedures such as herniated disc repair, biopsy, and harvesting autogenous bone.

Source page: https://510kreport.com/device/K113352
Methodology: https://510kreport.com/methodology