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FDA 510(k)

STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR

K-Number: K941896 · 1994-11-07

ApplicantDepuy, Inc.
Decision Date1994-11-07
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Depuy, Inc.. It received FDA 510(k) clearance on 1994-11-07 under 510(k) number K941896. 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 STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR?

STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR is a medical device that received FDA 510(k) clearance on 1994-11-07. The listed applicant is Depuy, Inc.. The 510(k) number is K941896.

When did STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR receive FDA 510(k) clearance?

STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR received FDA 510(k) clearance on 1994-11-07, under 510(k) number K941896.

Who is the listed applicant for STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR?

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

What is the FDA product code for STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR?

The FDA product code for STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR is LXH.

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Other records listing Depuy, 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.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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