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FDA 510(k)

BODYFORM THORACO-LUMBAR FIXATION SYSTEM

K-Number: K983622 · 1998-12-30

ApplicantTheken Surgical,Llc
Decision Date1998-12-30
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BODYFORM THORACO-LUMBAR FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theken Surgical,Llc. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K983622. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BODYFORM THORACO-LUMBAR FIXATION SYSTEM?

BODYFORM THORACO-LUMBAR FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Theken Surgical,Llc. The 510(k) number is K983622.

When did BODYFORM THORACO-LUMBAR FIXATION SYSTEM receive FDA 510(k) clearance?

BODYFORM THORACO-LUMBAR FIXATION SYSTEM received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983622.

Who is the listed applicant for BODYFORM THORACO-LUMBAR FIXATION SYSTEM?

The FDA 510(k) record lists Theken Surgical,Llc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BODYFORM THORACO-LUMBAR FIXATION SYSTEM?

The FDA product code for BODYFORM THORACO-LUMBAR FIXATION SYSTEM is KWQ.

Related Clinical Trials

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Other records listing Theken Surgical,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.

K050058THEKEN REVEAL VBR SYSTEMK032064THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEMK012462THEKEN LARGE CEMENT RESTRICTORK012278THEKEN SMALL CEMENT RESTRICTORK010466TETHER ACFS

Related Devices (Code: KWQ)

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.

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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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