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FDA 510(k)

SYNTEC OS SPINAL FIXATION SYSTEM

K-Number: K101971 · 2011-03-25

ApplicantSyntec Scientific Corp.
Decision Date2011-03-25
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTEC OS SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corp.. It received FDA 510(k) clearance on 2011-03-25 under 510(k) number K101971. 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 SYNTEC OS SPINAL FIXATION SYSTEM?

SYNTEC OS SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-25. The listed applicant is Syntec Scientific Corp.. The 510(k) number is K101971.

When did SYNTEC OS SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

SYNTEC OS SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2011-03-25, under 510(k) number K101971.

Who is the listed applicant for SYNTEC OS SPINAL FIXATION SYSTEM?

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

What is the FDA product code for SYNTEC OS SPINAL FIXATION SYSTEM?

The FDA product code for SYNTEC OS SPINAL FIXATION SYSTEM is NKB.

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Other records listing Syntec Scientific Corp. 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.

K111189SYNTEC DENTAL IMPLANTK092889SYNTEC OSTEO-PLATE AND SCREW FIXATIONK090476SYNTEC ORTHODONTIC MINI SCREWK090839MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTSK984602SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEMK984364SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100, 294-300,400 & 292-730/820

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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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