# K992457: SNN System with Olivier Double Chuck Support Arm Option

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Navigation Specialists, Inc.
- Decided: Aug 27, 1999 after 35 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- 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. The FDA summary names its predicate without a number.
- (no number) SNN image-guided surgical system: named in the summary without a submission number
- (no number) Philips EasyTaxis option to the EasyGuide system: named in the summary without a submission number
- (no number) Radionics Optical Tracking System with the frameless cranial biopsy indication: named in the summary without a submission number

## Indications for use
The SNN system with the Olivier Double-Chuck Support Arm Option is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine. The Olivier Double-Chuck Support Arm Option can provide mechanical support and guidance for various frameless stereotaxic procedures, tumor resections, biopsies, and endoscopies. The SNN system is contraindicated for patients suspected of having Creutzfeld-Jacob’s disease if adequate sterilization of the instruments cannot be assured.

Source page: https://510kreport.com/device/K992457
Methodology: https://510kreport.com/methodology