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FDA 510(k)

HIP ABDUCTION SPLINT

K-Number: K810557 · 1981-03-13

ApplicantOrthomedics
Decision Date1981-03-13
Product CodeIOZ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HIP ABDUCTION SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Orthomedics. It received FDA 510(k) clearance on 1981-03-13 under 510(k) number K810557. The device is classified under product code IOZ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIP ABDUCTION SPLINT?

HIP ABDUCTION SPLINT is a medical device that received FDA 510(k) clearance on 1981-03-13. The listed applicant is Orthomedics. The 510(k) number is K810557.

When did HIP ABDUCTION SPLINT receive FDA 510(k) clearance?

HIP ABDUCTION SPLINT received FDA 510(k) clearance on 1981-03-13, under 510(k) number K810557.

Who is the listed applicant for HIP ABDUCTION SPLINT?

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

What is the FDA product code for HIP ABDUCTION SPLINT?

The FDA product code for HIP ABDUCTION SPLINT is IOZ.

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Other records listing Orthomedics 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.

K832741JASON CERVICAL ORTHOSISK832742EXTENSION CONTROL KNEE ORTHOSISK832740FEMORAL FRACTURE ORTHOSISK811456ORTHO-FRAC KITK811297CERVICAL SUPPORTK811298EXECUTIVE COLLAR

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Related Devices (Code: IOZ)

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.

K830243ABDUCTION PILLOWWarm & Form, Orthopedic MaterialsK823820ABDUCTION PILLOWDanek Medical, Inc.K780375PAVLIK HARNESSBiomet, 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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