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FDA 510(k)

GSO PCT SPINAL SYSTEM

K-Number: K091359 · 2009-09-02

ApplicantGold Standard Orthopaedics, LLC
Decision Date2009-09-02
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GSO PCT SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Gold Standard Orthopaedics, LLC. It received FDA 510(k) clearance on 2009-09-02 under 510(k) number K091359. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSO PCT SPINAL SYSTEM?

GSO PCT SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-02. The listed applicant is Gold Standard Orthopaedics, LLC. The 510(k) number is K091359.

When did GSO PCT SPINAL SYSTEM receive FDA 510(k) clearance?

GSO PCT SPINAL SYSTEM received FDA 510(k) clearance on 2009-09-02, under 510(k) number K091359.

Who is the listed applicant for GSO PCT SPINAL SYSTEM?

The FDA 510(k) record lists Gold Standard Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSO PCT SPINAL SYSTEM?

The FDA product code for GSO PCT SPINAL SYSTEM is KWP.

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 Gold Standard Orthopaedics, LLC 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.

K123487GSO GS1 CANNULATED SCREW SYSTEMK070966GSO GS1 SPINAL SYSTEMK063589GSO BONE FIXATION FASTENERS

Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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