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FDA 510(k)

FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY

K-Number: K100044 · 2010-02-04

ApplicantBlackstone
Decision Date2010-02-04
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY is the device name listed in this FDA 510(k) record. The listed applicant is Blackstone. It received FDA 510(k) clearance on 2010-02-04 under 510(k) number K100044. 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 FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY?

FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY is a medical device that received FDA 510(k) clearance on 2010-02-04. The listed applicant is Blackstone. The 510(k) number is K100044.

When did FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY receive FDA 510(k) clearance?

FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY received FDA 510(k) clearance on 2010-02-04, under 510(k) number K100044.

Who is the listed applicant for FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY?

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

What is the FDA product code for FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY?

The FDA product code for FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY is NKB.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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