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FDA 510(k)

Posterior Spinal Fixation System

K-Number: K201737 · 2021-06-21

ApplicantShanghai Reach Medical Instrument Co, Ltd.
Decision Date2021-06-21
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Posterior Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Reach Medical Instrument Co, Ltd.. It received FDA 510(k) clearance on 2021-06-21 under 510(k) number K201737. 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 Posterior Spinal Fixation System?

Posterior Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2021-06-21. The listed applicant is Shanghai Reach Medical Instrument Co, Ltd.. The 510(k) number is K201737.

When did Posterior Spinal Fixation System receive FDA 510(k) clearance?

Posterior Spinal Fixation System received FDA 510(k) clearance on 2021-06-21, under 510(k) number K201737.

Who is the listed applicant for Posterior Spinal Fixation System?

The FDA 510(k) record lists Shanghai Reach Medical Instrument Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Posterior Spinal Fixation System?

The FDA product code for Posterior Spinal Fixation System is NKB.

Related Clinical Trials

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.

NCT03118505A Study of Infuse® Bone Graft With Mastergraft® Strip and Posterior Fixation for Posterolateral Fusion (PLF) Treatment of Multi-Level Degenerative Lumbosacral Spinal ConditionsACTIVE_NOT_RECRUITING

Other records listing Shanghai Reach Medical Instrument Co, Ltd. 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.

K232069Expandable Lumbar Fusion Cage (Type I,Type II)K221745Sterile Posterior Spinal Fixation System

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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