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FDA 510(k)

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL

K-Number: K043233 · 2005-02-01

ApplicantEfratgo, Ltd. HI Tech Bio-Surgical
Decision Date2005-02-01
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Efratgo, Ltd. HI Tech Bio-Surgical. It received FDA 510(k) clearance on 2005-02-01 under 510(k) number K043233. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL?

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL is a medical device that received FDA 510(k) clearance on 2005-02-01. The listed applicant is Efratgo, Ltd. HI Tech Bio-Surgical. The 510(k) number is K043233.

When did GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL receive FDA 510(k) clearance?

GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL received FDA 510(k) clearance on 2005-02-01, under 510(k) number K043233.

Who is the listed applicant for GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL?

The FDA 510(k) record lists Efratgo, Ltd. HI Tech Bio-Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL?

The FDA product code for GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL is HSB.

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Other records listing Efratgo, Ltd. HI Tech Bio-Surgical 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.

K083648GOTFRIED PHYSIOLOGICAL HIP (PH) NAILK983814GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM

Related Devices (Code: HSB)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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