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FDA 510(k)

SUTTER PHALANGEAL CAP

K-Number: K875249 · 1988-02-03

ApplicantSutter Biomedical, Inc.
Decision Date1988-02-03
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTTER PHALANGEAL CAP is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Biomedical, Inc.. It received FDA 510(k) clearance on 1988-02-03 under 510(k) number K875249. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUTTER PHALANGEAL CAP?

SUTTER PHALANGEAL CAP is a medical device that received FDA 510(k) clearance on 1988-02-03. The listed applicant is Sutter Biomedical, Inc.. The 510(k) number is K875249.

When did SUTTER PHALANGEAL CAP receive FDA 510(k) clearance?

SUTTER PHALANGEAL CAP received FDA 510(k) clearance on 1988-02-03, under 510(k) number K875249.

Who is the listed applicant for SUTTER PHALANGEAL CAP?

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

What is the FDA product code for SUTTER PHALANGEAL CAP?

The FDA product code for SUTTER PHALANGEAL CAP is KWD.

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Other records listing Sutter Biomedical, 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.

K870200SUTTER FINGER JOINT PROSTHESISK861983SUTTER LESSER METATARSAL CAPK850274SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENTK830974SUTTER CPM 5000K830649SUTTER CPM 2000K823539SUTTER CPM

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Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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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