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FDA 510(k)

ORTHOPEDIC SOFT GOODS

K-Number: K771109 · 1977-06-27

ApplicantOrthopedic Systems, Inc.
Decision Date1977-06-27
Product CodeHSS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC SOFT GOODS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Systems, Inc.. It received FDA 510(k) clearance on 1977-06-27 under 510(k) number K771109. The device is classified under product code HSS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOPEDIC SOFT GOODS?

ORTHOPEDIC SOFT GOODS is a medical device that received FDA 510(k) clearance on 1977-06-27. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K771109.

When did ORTHOPEDIC SOFT GOODS receive FDA 510(k) clearance?

ORTHOPEDIC SOFT GOODS received FDA 510(k) clearance on 1977-06-27, under 510(k) number K771109.

Who is the listed applicant for ORTHOPEDIC SOFT GOODS?

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

What is the FDA product code for ORTHOPEDIC SOFT GOODS?

The FDA product code for ORTHOPEDIC SOFT GOODS is HSS.

Related Clinical Trials

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Other records listing Orthopedic Systems, 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.

K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMK920256SPINE MOTION ANALYZER WITH EMGK910736JACKSON MULTIPURPOSE OPERATING TABLEK910031PARK CITY SHOULDER POSITIONERK903938C FIT CUPK892503NUFFIELD TOTAL KNEE

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Related Devices (Code: HSS)

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.

K770910MEDISHIELD CERVICAL COLLARFraser Sweatman, Inc.K760869SPLIT CERVICAL COLLAR/HEAD HALTEROrthopedic Equipment Co., 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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