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FDA 510(k)

ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL

K-Number: K112663 · 2012-03-12

ApplicantEnhatch Orthopaedics, LLC
Decision Date2012-03-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL is the device name listed in this FDA 510(k) record. The listed applicant is Enhatch Orthopaedics, LLC. It received FDA 510(k) clearance on 2012-03-12 under 510(k) number K112663. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL?

ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL is a medical device that received FDA 510(k) clearance on 2012-03-12. The listed applicant is Enhatch Orthopaedics, LLC. The 510(k) number is K112663.

When did ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL receive FDA 510(k) clearance?

ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL received FDA 510(k) clearance on 2012-03-12, under 510(k) number K112663.

Who is the listed applicant for ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL?

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

What is the FDA product code for ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL?

The FDA product code for ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL is HRS.

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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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