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FDA 510(k)

SPLINH, FOREARM

K-Number: K770891 · 1977-05-26

ApplicantOrthopedic Systems, Inc.
Decision Date1977-05-26
Product CodeIQM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SPLINH, FOREARM 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 1977-05-26 under 510(k) number K770891. The device is classified under product code IQM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLINH, FOREARM?

SPLINH, FOREARM is a medical device that received FDA 510(k) clearance on 1977-05-26. The listed applicant is Orthopedic Systems, Inc.. The 510(k) number is K770891.

When did SPLINH, FOREARM receive FDA 510(k) clearance?

SPLINH, FOREARM received FDA 510(k) clearance on 1977-05-26, under 510(k) number K770891.

Who is the listed applicant for SPLINH, FOREARM?

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 SPLINH, FOREARM?

The FDA product code for SPLINH, FOREARM is IQM.

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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: IQM)

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.

K771287FINGEO EXTENSION SPLINTSFred Sammons, Inc.K770890SPLINT, COCKUPOrthopedic Systems, 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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