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FDA 510(k)

BODYFORM THORACIC FIXATION SYSTEM

K-Number: K072407 · 2007-12-21

ApplicantTheken Spine, LLC
Decision Date2007-12-21
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BODYFORM THORACIC FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theken Spine, LLC. It received FDA 510(k) clearance on 2007-12-21 under 510(k) number K072407. 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 THORACIC FIXATION SYSTEM?

BODYFORM THORACIC FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-12-21. The listed applicant is Theken Spine, LLC. The 510(k) number is K072407.

When did BODYFORM THORACIC FIXATION SYSTEM receive FDA 510(k) clearance?

BODYFORM THORACIC FIXATION SYSTEM received FDA 510(k) clearance on 2007-12-21, under 510(k) number K072407.

Who is the listed applicant for BODYFORM THORACIC FIXATION SYSTEM?

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

What is the FDA product code for BODYFORM THORACIC FIXATION SYSTEM?

The FDA product code for BODYFORM THORACIC FIXATION SYSTEM is KWQ.

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Other records listing Theken Spine, 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.

K121482INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYK121211VU APOD INTERVERTEBRAL BODY FUSION DEVICEK120829STAINLESS STEEL SPINAL SYSTEMK120047CORAL SPINAL SYSTEMK111675VU C*POD INTERVERTEBRAL BODY FUSION DEVICEK103228PARAMOUNT R IBF DEVICE

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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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