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FDA 510(k)

SCREW, WADSWORTH OLECRANON

K-Number: K770035 · 1977-01-14

ApplicantOrthopedic Equipment Co., Inc.
Decision Date1977-01-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCREW, WADSWORTH OLECRANON is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Equipment Co., Inc.. It received FDA 510(k) clearance on 1977-01-14 under 510(k) number K770035. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCREW, WADSWORTH OLECRANON?

SCREW, WADSWORTH OLECRANON is a medical device that received FDA 510(k) clearance on 1977-01-14. The listed applicant is Orthopedic Equipment Co., Inc.. The 510(k) number is K770035.

When did SCREW, WADSWORTH OLECRANON receive FDA 510(k) clearance?

SCREW, WADSWORTH OLECRANON received FDA 510(k) clearance on 1977-01-14, under 510(k) number K770035.

Who is the listed applicant for SCREW, WADSWORTH OLECRANON?

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

What is the FDA product code for SCREW, WADSWORTH OLECRANON?

The FDA product code for SCREW, WADSWORTH OLECRANON is HWC. This falls under the Cardiovascular category.

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Other records listing Orthopedic Equipment Co., Inc. as applicant

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Related Devices (Code: HWC)

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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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