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FDA 510(k)

USS ILIOSACRAL, USS POLYAXIAL

K-Number: K082572 · 2008-11-24

ApplicantSynthes Spine
Decision Date2008-11-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

USS ILIOSACRAL, USS POLYAXIAL is the device name listed in this FDA 510(k) record. The listed applicant is Synthes Spine. It received FDA 510(k) clearance on 2008-11-24 under 510(k) number K082572. 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 USS ILIOSACRAL, USS POLYAXIAL?

USS ILIOSACRAL, USS POLYAXIAL is a medical device that received FDA 510(k) clearance on 2008-11-24. The listed applicant is Synthes Spine. The 510(k) number is K082572.

When did USS ILIOSACRAL, USS POLYAXIAL receive FDA 510(k) clearance?

USS ILIOSACRAL, USS POLYAXIAL received FDA 510(k) clearance on 2008-11-24, under 510(k) number K082572.

Who is the listed applicant for USS ILIOSACRAL, USS POLYAXIAL?

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

What is the FDA product code for USS ILIOSACRAL, USS POLYAXIAL?

The FDA product code for USS ILIOSACRAL, USS POLYAXIAL is NKB.

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Other records listing Synthes Spine 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.

K122211SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTSK120838SYNTHES MATRIX SYSTEMK111048SYNTHES SCOUT TACK FIXATIONK120928SYNTHES MATRIX SYSTEMK120571SYNTHES USS CONNECTORK113149SYNTHES USS CONNECTORS

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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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