# K990474: Oratec Interventions Ora-50 S Programmable Electrothermal Spine System and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Oratec Interventions, Inc.
- Decided: May 17, 1999 after 90 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 K964071 (1996). 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)
- K964071: Oratec Interventions Model Ora 50 Electrothermal Generator, Oratec Interventions, Inc. (1996) Summary page 1.

## Indications for use
The ORA-50 S Programmable ElectroThermal Spine System and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S Programmable ElectroThermal Spine System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Source page: https://510kreport.com/device/K990474
Methodology: https://510kreport.com/methodology