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FDA 510(k)

ORTHOSIS BANDAGES

K-Number: K810877 · 1981-04-17

ApplicantOrtho-Cast, Inc.
Decision Date1981-04-17
Product CodeITG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ORTHOSIS BANDAGES is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Cast, Inc.. It received FDA 510(k) clearance on 1981-04-17 under 510(k) number K810877. The device is classified under product code ITG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOSIS BANDAGES?

ORTHOSIS BANDAGES is a medical device that received FDA 510(k) clearance on 1981-04-17. The listed applicant is Ortho-Cast, Inc.. The 510(k) number is K810877.

When did ORTHOSIS BANDAGES receive FDA 510(k) clearance?

ORTHOSIS BANDAGES received FDA 510(k) clearance on 1981-04-17, under 510(k) number K810877.

Who is the listed applicant for ORTHOSIS BANDAGES?

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

What is the FDA product code for ORTHOSIS BANDAGES?

The FDA product code for ORTHOSIS BANDAGES is ITG.

Related Clinical Trials

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.

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Related Devices (Code: ITG)

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.

K873111CONFORMA(TM) PLASTER BANDAGESThe Kendal Co.K862115DEKNA BAND KITDeknatel, Inc.K842573T.P.G. CAST TAPEThe Poly Group, Inc.K840416HEXCELITEHexcel MedicalK833732NON WETTING UNDERCAST PADDINGAmerican Medical Disposable, Inc.K832992SOFFBAN ORTHOPEDIC PADDINGSmith & Nephew, 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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