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FDA 510(k)

STAINLESS STEEL SPINAL SYSTEM

K-Number: K100970 · 2010-08-12

ApplicantTheken Spine, LLC
Decision Date2010-08-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STAINLESS STEEL SPINAL 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 2010-08-12 under 510(k) number K100970. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAINLESS STEEL SPINAL SYSTEM?

STAINLESS STEEL SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-08-12. The listed applicant is Theken Spine, LLC. The 510(k) number is K100970.

When did STAINLESS STEEL SPINAL SYSTEM receive FDA 510(k) clearance?

STAINLESS STEEL SPINAL SYSTEM received FDA 510(k) clearance on 2010-08-12, under 510(k) number K100970.

Who is the listed applicant for STAINLESS STEEL SPINAL 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 STAINLESS STEEL SPINAL SYSTEM?

The FDA product code for STAINLESS STEEL SPINAL SYSTEM is NKB.

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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: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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