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FDA 510(k)

SYNTHES XRL

K-Number: K103320 · 2011-10-20

ApplicantSynthes Spine Co.Lp
Decision Date2011-10-20
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES XRL 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 2011-10-20 under 510(k) number K103320. 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 XRL?

SYNTHES XRL is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is Synthes Spine Co.Lp. The 510(k) number is K103320.

When did SYNTHES XRL receive FDA 510(k) clearance?

SYNTHES XRL received FDA 510(k) clearance on 2011-10-20, under 510(k) number K103320.

Who is the listed applicant for SYNTHES XRL?

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 XRL?

The FDA product code for SYNTHES XRL 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)K081568ANTEGRA-TK080020ARCOFIXK072981SYNTHES ZERO-P

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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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