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FDA 510(k)

TENDON ROD MODEL OR41PO3-6

K-Number: K781943 · 1978-12-04

ApplicantHolter-Hausner Intl.
Decision Date1978-12-04
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TENDON ROD MODEL OR41PO3-6 is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781943. The device is classified under product code HXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENDON ROD MODEL OR41PO3-6?

TENDON ROD MODEL OR41PO3-6 is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K781943.

When did TENDON ROD MODEL OR41PO3-6 receive FDA 510(k) clearance?

TENDON ROD MODEL OR41PO3-6 received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781943.

Who is the listed applicant for TENDON ROD MODEL OR41PO3-6?

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

What is the FDA product code for TENDON ROD MODEL OR41PO3-6?

The FDA product code for TENDON ROD MODEL OR41PO3-6 is HXA.

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Other records listing Holter-Hausner Intl. 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.

K875287H-H FLUSHING RESERVOIRK874508H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAGK872285H-H HUNTER ACTIVE TENDON IMPLANT DCK872284H-H HUNTER ACTIVE TENDON IMPLANT PCK872293H-H HUNTER ACTIVE TENDON IMPLANT BCK871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP

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Related Devices (Code: HXA)

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.

K243477Universal Tendon SpacerAskorn MedicalK000019SINGLE SIZE TENDON SPACERMedist InternationalK973385OVAL SHAPESTechnical Products, Inc.K964359AVANTA ORTHOPAEDICS TENDON SPACERAvanta Orthopaedics, Inc.K930125PHOENIX BONE SCREWS PBS-TYPE SERIESPhoenix Bioengineering, Inc.K872284H-H HUNTER ACTIVE TENDON IMPLANT PCHolter-Hausner Intl.

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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