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FDA 510(k)

Wiltrom Spinal Fixation System

K-Number: K202894 · 2020-10-23

ApplicantWiltrom Corporation Limited
Decision Date2020-10-23
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Wiltrom Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Wiltrom Corporation Limited. It received FDA 510(k) clearance on 2020-10-23 under 510(k) number K202894. 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 Wiltrom Spinal Fixation System?

Wiltrom Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2020-10-23. The listed applicant is Wiltrom Corporation Limited. The 510(k) number is K202894.

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

Wiltrom Spinal Fixation System received FDA 510(k) clearance on 2020-10-23, under 510(k) number K202894.

Who is the listed applicant for Wiltrom Spinal Fixation System?

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

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

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

Other records listing Wiltrom Corporation Limited 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.

K180758Osteocera Resorbable Bone SubstituteK172237Bicera Resorbable Bone SubstituteK172548Wiltrom 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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