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FDA 510(k)

H-H HUNTER ACTIVE TENDON IMPLANT

K-Number: K853438 · 1985-09-30

ApplicantHolter-Hausner Intl.
Decision Date1985-09-30
Product CodeHXA
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

H-H HUNTER ACTIVE 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 1985-09-30 under 510(k) number K853438. The device is classified under product code HXA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the H-H HUNTER ACTIVE TENDON IMPLANT?

H-H HUNTER ACTIVE TENDON IMPLANT is a medical device that received FDA 510(k) clearance on 1985-09-30. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K853438.

When did H-H HUNTER ACTIVE TENDON IMPLANT receive FDA 510(k) clearance?

H-H HUNTER ACTIVE TENDON IMPLANT received FDA 510(k) clearance on 1985-09-30, under 510(k) number K853438.

Who is the listed applicant for H-H HUNTER ACTIVE 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 H-H HUNTER ACTIVE TENDON IMPLANT?

The FDA product code for H-H HUNTER ACTIVE 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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