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FDA 510(k)

CANCELLOUS SCREW WASHER

K-Number: K963420 · 1996-11-15

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date1996-11-15
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CANCELLOUS SCREW WASHER is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems, Ltd.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K963420. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CANCELLOUS SCREW WASHER?

CANCELLOUS SCREW WASHER is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K963420.

When did CANCELLOUS SCREW WASHER receive FDA 510(k) clearance?

CANCELLOUS SCREW WASHER received FDA 510(k) clearance on 1996-11-15, under 510(k) number K963420.

Who is the listed applicant for CANCELLOUS SCREW WASHER?

The FDA 510(k) record lists Orthopaedic Biosystems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CANCELLOUS SCREW WASHER?

The FDA product code for CANCELLOUS SCREW WASHER is HTN.

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Other records listing Orthopaedic Biosystems, Ltd. 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.

K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONK983169POLYMER THREADED ANCHORK982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONK972326PEBA ANCHOR/SUTURE COMBINATIONK963432GUIDE WIRES FOR CANNULATED SCREWS

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Related Devices (Code: HTN)

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.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, 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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