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FDA 510(k)

POWEReam 1/4 Drive

K-Number: K233300 · 2023-12-26

ApplicantStryker Instruments
Decision Date2023-12-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POWEReam 1/4 Drive is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2023-12-26 under 510(k) number K233300. 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 POWEReam 1/4 Drive?

POWEReam 1/4 Drive is a medical device that received FDA 510(k) clearance on 2023-12-26. The listed applicant is Stryker Instruments. The 510(k) number is K233300.

When did POWEReam 1/4 Drive receive FDA 510(k) clearance?

POWEReam 1/4 Drive received FDA 510(k) clearance on 2023-12-26, under 510(k) number K233300.

Who is the listed applicant for POWEReam 1/4 Drive?

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

What is the FDA product code for POWEReam 1/4 Drive?

The FDA product code for POWEReam 1/4 Drive is NKB.

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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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