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FDA 510(k)

MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM

K-Number: K080790 · 2008-04-29

ApplicantTheken Spine, LLC
Decision Date2008-04-29
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC 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 2008-04-29 under 510(k) number K080790. 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 MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM?

MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM is a medical device that received FDA 510(k) clearance on 2008-04-29. The listed applicant is Theken Spine, LLC. The 510(k) number is K080790.

When did MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM received FDA 510(k) clearance on 2008-04-29, under 510(k) number K080790.

Who is the listed applicant for MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC 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 MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM?

The FDA product code for MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM is KWP.

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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: 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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