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FDA 510(k)

PINE Pedicle Screw System

K-Number: K220285 · 2022-05-19

ApplicantTdm Co., Ltd.
Decision Date2022-05-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PINE Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K220285. 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 PINE Pedicle Screw System?

PINE Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K220285.

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

PINE Pedicle Screw System received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220285.

Who is the listed applicant for PINE Pedicle Screw System?

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

What is the FDA product code for PINE Pedicle Screw System?

The FDA product code for PINE Pedicle Screw System is NKB.

Other records listing Tdm 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.

K241128TDM Plate and Screw SystemK230071Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail SystemK240423TDM Anterior Cervical Plate SystemK232115TDM Large Bone Plate and Screw SystemK231860TDM Screw SystemK221844TDM Lumbar Interbody Fusion Cage System

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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.

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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