# K071138: Cranioclamp Bioabsorbable Cranial Bone Flap Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Prosurg, Inc.
- Decided: Aug 15, 2007 after 152 days
- Product code: GXR (Cover, Burr Hole)
- Device class: 2
- Regulation: 21 CFR 882.5250
- 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 CranioClamp TM - Bioabsobable Cranial Bone Flap Fixation System is intended for use in covering burr holes and for fixation of cranial bone flaps after craniotomy

Source page: https://510kreport.com/device/K071138
Methodology: https://510kreport.com/methodology