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FDA 510(k)

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY

K-Number: K943873 · 1995-04-26

ApplicantOrthomet, Inc.
Decision Date1995-04-26
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY is the device name listed in this FDA 510(k) record. The listed applicant is Orthomet, Inc.. It received FDA 510(k) clearance on 1995-04-26 under 510(k) number K943873. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY?

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY is a medical device that received FDA 510(k) clearance on 1995-04-26. The listed applicant is Orthomet, Inc.. The 510(k) number is K943873.

When did ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY receive FDA 510(k) clearance?

ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY received FDA 510(k) clearance on 1995-04-26, under 510(k) number K943873.

Who is the listed applicant for ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY?

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

What is the FDA product code for ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY?

The FDA product code for ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY is LXH.

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Other records listing Orthomet, Inc. as applicant

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Related Devices (Code: LXH)

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.

K192873SX-One MicroKnifeSonex Health, Inc.K101609SELF RETAINING SOFT TISSUE RETRACTORKoros USA, Inc.K001507MICROPERFORATION INSTRUMENTSmith & Nephew, Inc.K952495ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEMOrthopedic Systems, Inc.K944188SPINAL MARKERLeibinger L.P.K941896STEADMAN LIGAMENT GRAFT PASSER AND PROTECTORDepuy, Inc.

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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