FDA 510(k)

ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES

K-Number: K990474 · 1999-05-17

Decision Date1999-05-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Oratec Interventions, Inc.. It received FDA 510(k) clearance on 1999-05-17 under 510(k) number K990474. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES?

ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1999-05-17. The listed applicant is Oratec Interventions, Inc.. The 510(k) number is K990474.

When did ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1999-05-17, under 510(k) number K990474.

Who is the listed applicant for ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES?

The FDA 510(k) record lists Oratec Interventions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES?

The FDA product code for ORATEC INTERVENTIONS ORA-50 S PROGRAMMABLE ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES is GEI.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.