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FDA 510(k)

Goblin and Goblin LS Pedicle Screw Systems

K-Number: K210420 · 2021-04-19

ApplicantMedynus, Inc.
Decision Date2021-04-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Goblin and Goblin LS Pedicle Screw Systems is the device name listed in this FDA 510(k) record. The listed applicant is Medynus, Inc.. It received FDA 510(k) clearance on 2021-04-19 under 510(k) number K210420. 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 Goblin and Goblin LS Pedicle Screw Systems?

Goblin and Goblin LS Pedicle Screw Systems is a medical device that received FDA 510(k) clearance on 2021-04-19. The listed applicant is Medynus, Inc.. The 510(k) number is K210420.

When did Goblin and Goblin LS Pedicle Screw Systems receive FDA 510(k) clearance?

Goblin and Goblin LS Pedicle Screw Systems received FDA 510(k) clearance on 2021-04-19, under 510(k) number K210420.

Who is the listed applicant for Goblin and Goblin LS Pedicle Screw Systems?

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

What is the FDA product code for Goblin and Goblin LS Pedicle Screw Systems?

The FDA product code for Goblin and Goblin LS Pedicle Screw Systems is NKB.

Other records listing Medynus, Inc. 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.

K220379IMPEACE and IMPEACE-Uni Anterior Cervical Plate SystemK212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage

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

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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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