# K131851: Osteomed Neuro Rongeur

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed
- Decided: Dec 6, 2013 after 168 days
- Product code: HAE (Rongeur, Manual)
- Device class: 2
- Regulation: 21 CFR 882.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943635 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081651: Instrumed Rongeur, Instrumed International, Inc. (2008) Summary page 1.
- K092227: Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs, Integra Lifesciences Corp. (2010) Summary page 2.

## Indications for use
The OsteoMed Neuro Rongeur is a manually operated instrument indicated for cutting or biting bone during surgery involving the skull or spinal column.

Source page: https://510kreport.com/device/K131851
Methodology: https://510kreport.com/methodology