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FDA 510(k)

Seneka II Polyscrew Pedicle Fixation System

K-Number: K153525 · 2016-01-28

ApplicantSenecka Spine
Decision Date2016-01-28
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Seneka II Polyscrew Pedicle Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Senecka Spine. It received FDA 510(k) clearance on 2016-01-28 under 510(k) number K153525. 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 Seneka II Polyscrew Pedicle Fixation System?

Seneka II Polyscrew Pedicle Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-28. The listed applicant is Senecka Spine. The 510(k) number is K153525.

When did Seneka II Polyscrew Pedicle Fixation System receive FDA 510(k) clearance?

Seneka II Polyscrew Pedicle Fixation System received FDA 510(k) clearance on 2016-01-28, under 510(k) number K153525.

Who is the listed applicant for Seneka II Polyscrew Pedicle Fixation System?

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

What is the FDA product code for Seneka II Polyscrew Pedicle Fixation System?

The FDA product code for Seneka II Polyscrew Pedicle Fixation System is NKB.

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.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak 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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