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FDA 510(k)

Calvary Spine Pedicle Screw System

K-Number: K201568 · 2020-11-12

ApplicantCalvary Spine, LLC
Decision Date2020-11-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Calvary Spine Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Calvary Spine, LLC. It received FDA 510(k) clearance on 2020-11-12 under 510(k) number K201568. 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 Calvary Spine Pedicle Screw System?

Calvary Spine Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-11-12. The listed applicant is Calvary Spine, LLC. The 510(k) number is K201568.

When did Calvary Spine Pedicle Screw System receive FDA 510(k) clearance?

Calvary Spine Pedicle Screw System received FDA 510(k) clearance on 2020-11-12, under 510(k) number K201568.

Who is the listed applicant for Calvary Spine Pedicle Screw System?

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

What is the FDA product code for Calvary Spine Pedicle Screw System?

The FDA product code for Calvary Spine Pedicle Screw 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.

NCT05565131Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine SurgeryCOMPLETED

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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