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FDA 510(k)

SOFAMOR ORTHOPAEDIC INSTRUMENTS

K-Number: K933242 · 1994-01-28

ApplicantDanek Medical, Inc.
Decision Date1994-01-28
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SOFAMOR ORTHOPAEDIC INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Danek Medical, Inc.. It received FDA 510(k) clearance on 1994-01-28 under 510(k) number K933242. 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 SOFAMOR ORTHOPAEDIC INSTRUMENTS?

SOFAMOR ORTHOPAEDIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-01-28. The listed applicant is Danek Medical, Inc.. The 510(k) number is K933242.

When did SOFAMOR ORTHOPAEDIC INSTRUMENTS receive FDA 510(k) clearance?

SOFAMOR ORTHOPAEDIC INSTRUMENTS received FDA 510(k) clearance on 1994-01-28, under 510(k) number K933242.

Who is the listed applicant for SOFAMOR ORTHOPAEDIC INSTRUMENTS?

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

What is the FDA product code for SOFAMOR ORTHOPAEDIC INSTRUMENTS?

The FDA product code for SOFAMOR ORTHOPAEDIC INSTRUMENTS is LXH.

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Other records listing Danek Medical, 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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