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FDA 510(k)

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT

K-Number: K924654 · 1993-02-22

ApplicantSutter Corp.
Decision Date1993-02-22
Product CodeBXB
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Corp.. It received FDA 510(k) clearance on 1993-02-22 under 510(k) number K924654. The device is classified under product code BXB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT?

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT is a medical device that received FDA 510(k) clearance on 1993-02-22. The listed applicant is Sutter Corp.. The 510(k) number is K924654.

When did FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT receive FDA 510(k) clearance?

FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT received FDA 510(k) clearance on 1993-02-22, under 510(k) number K924654.

Who is the listed applicant for FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT?

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

What is the FDA product code for FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT?

The FDA product code for FIRST METATARSOPHALANGEAL JOINT MOTION SPLINT is BXB.

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Other records listing Sutter Corp. 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.

K943354SUTTER HAMMERTOE JOINT PROSTHESISK945221SUTTER MODEL 6000 HAND CPM DEVICEK931588SUTTER PROXIMAL INTERPHALANGEAL JOINTK914860SUTTER MODEL 10000 LEG CPM DEVICEK902707MODEL 9000 AT ANKLE CPM DEVICEK890607SUTTER HOSPITAL CPM

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Related Devices (Code: BXB)

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.

K072887G-TRAINER MEDICALAlter-G, Inc.K003272FLO-BOOTDiscovery Group, LLCK952975ANKLE CALF EXERCISER PHLEBOPUMPPrevent Products, Inc.K953456E-Z FLEXFluid Motion Biotechnologies, Inc.K955106BTE CPM-20Baltimore Therapeutic Equipment Co.K955105BTE CPM-10Baltimore Therapeutic Equipment Co.

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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