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FDA 510(k)

SUTTER LESSER METATARSAL CAP

K-Number: K861983 · 1986-09-08

ApplicantSutter Biomedical, Inc.
Decision Date1986-09-08
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SUTTER LESSER METATARSAL 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 1986-09-08 under 510(k) number K861983. 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 LESSER METATARSAL CAP?

SUTTER LESSER METATARSAL CAP is a medical device that received FDA 510(k) clearance on 1986-09-08. The listed applicant is Sutter Biomedical, Inc.. The 510(k) number is K861983.

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

SUTTER LESSER METATARSAL CAP received FDA 510(k) clearance on 1986-09-08, under 510(k) number K861983.

Who is the listed applicant for SUTTER LESSER METATARSAL 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 LESSER METATARSAL CAP?

The FDA product code for SUTTER LESSER METATARSAL 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.

K875249SUTTER PHALANGEAL CAPK870200SUTTER FINGER JOINT PROSTHESISK850274SUTTER 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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