# K970306: Markman Template System

- Pathway: 510(k) (Traditional)
- Applicant: Barry Markman, M.D.
- Decided: Nov 20, 1997 after 297 days
- Product code: GAH (Stylet, Surgical, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Template System will be used solely for hair restoration. The device will first create slits in a recipient site in the scalp, and then insert hair grafts into these slits. Cartridges preloaded with hair grafts will facilitate insertion in an efficient manner.

Source page: https://510kreport.com/device/K970306
Methodology: https://510kreport.com/methodology