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FDA 510(k)

ORTHOPEDIC CUSTOM SURGICAL KIT

K-Number: K844595 · 1985-08-21

ApplicantXanmed Corp.
Decision Date1985-08-21
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOPEDIC CUSTOM SURGICAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Xanmed Corp.. It received FDA 510(k) clearance on 1985-08-21 under 510(k) number K844595. 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 ORTHOPEDIC CUSTOM SURGICAL KIT?

ORTHOPEDIC CUSTOM SURGICAL KIT is a medical device that received FDA 510(k) clearance on 1985-08-21. The listed applicant is Xanmed Corp.. The 510(k) number is K844595.

When did ORTHOPEDIC CUSTOM SURGICAL KIT receive FDA 510(k) clearance?

ORTHOPEDIC CUSTOM SURGICAL KIT received FDA 510(k) clearance on 1985-08-21, under 510(k) number K844595.

Who is the listed applicant for ORTHOPEDIC CUSTOM SURGICAL KIT?

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

What is the FDA product code for ORTHOPEDIC CUSTOM SURGICAL KIT?

The FDA product code for ORTHOPEDIC CUSTOM SURGICAL KIT is LXH.

Related Clinical Trials

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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Other records listing Xanmed Corp. 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.

K864623OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KITK844596EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KITK844593CARDIOVASCULAR CUSTOM SURGICAL KITK844594NEURO CUSTOM SURGICAL KITK851906SURGICAL EYE PACKK844597MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT

View all 9 devices →

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.K943873ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SYOrthomet, Inc.K944188SPINAL MARKERLeibinger L.P.

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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