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FDA 510(k)

PASSIVE TENDON IMPLANT

K-Number: K780320 · 1978-03-17

ApplicantHolter-Hausner Intl.
Decision Date1978-03-17
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PASSIVE TENDON IMPLANT 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 1978-03-17 under 510(k) number K780320. 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 PASSIVE TENDON IMPLANT?

PASSIVE TENDON IMPLANT is a medical device that received FDA 510(k) clearance on 1978-03-17. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K780320.

When did PASSIVE TENDON IMPLANT receive FDA 510(k) clearance?

PASSIVE TENDON IMPLANT received FDA 510(k) clearance on 1978-03-17, under 510(k) number K780320.

Who is the listed applicant for PASSIVE TENDON IMPLANT?

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 PASSIVE TENDON IMPLANT?

The FDA product code for PASSIVE TENDON IMPLANT 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 BAGK872293H-H HUNTER ACTIVE TENDON IMPLANT BCK872285H-H HUNTER ACTIVE TENDON IMPLANT DCK872284H-H HUNTER ACTIVE TENDON IMPLANT PCK871351H-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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