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FDA 510(k)

SYNTHES ORACLE SPACER

K-Number: K062933 · 2007-01-31

ApplicantSynthes Spine Co.Lp
Decision Date2007-01-31
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES ORACLE SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine Co.Lp. It received FDA 510(k) clearance on 2007-01-31 under 510(k) number K062933. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES ORACLE SPACER?

SYNTHES ORACLE SPACER is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K062933.

When did SYNTHES ORACLE SPACER receive FDA 510(k) clearance?

SYNTHES ORACLE SPACER received FDA 510(k) clearance on 2007-01-31, under 510(k) number K062933.

Who is the listed applicant for SYNTHES ORACLE SPACER?

The FDA 510(k) record lists Synthes Spine Co.Lp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES ORACLE SPACER?

The FDA product code for SYNTHES ORACLE SPACER is MQP.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Synthes Spine Co.Lp as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)K112459SYNTHES ZERO-PK112068SYNTHES ZERO-P VARIABLE ANGLE (VA)K103320SYNTHES XRLK081568ANTEGRA-TK080020ARCOFIX

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Related Devices (Code: MQP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

Official Source

View on FDA Database →

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

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