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FDA 510(k)

ADAPTIVE WEDGE

K-Number: K110662 · 2012-03-12

ApplicantAdaptive Specialty, LLC
Decision Date2012-03-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADAPTIVE WEDGE is the device name listed in this FDA 510(k) record. The listed applicant is Adaptive Specialty, LLC. It received FDA 510(k) clearance on 2012-03-12 under 510(k) number K110662. 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 ADAPTIVE WEDGE?

ADAPTIVE WEDGE is a medical device that received FDA 510(k) clearance on 2012-03-12. The listed applicant is Adaptive Specialty, LLC. The 510(k) number is K110662.

When did ADAPTIVE WEDGE receive FDA 510(k) clearance?

ADAPTIVE WEDGE received FDA 510(k) clearance on 2012-03-12, under 510(k) number K110662.

Who is the listed applicant for ADAPTIVE WEDGE?

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

What is the FDA product code for ADAPTIVE WEDGE?

The FDA product code for ADAPTIVE WEDGE is HRS.

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Other records listing Adaptive Specialty, LLC 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.

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Related Devices (Code: HRS)

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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