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FDA 510(k)

RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS

K-Number: K901289 · 1990-09-28

ApplicantMumtaz I. Malik
Decision Date1990-09-28
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Mumtaz I. Malik. It received FDA 510(k) clearance on 1990-09-28 under 510(k) number K901289. 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 RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS?

RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1990-09-28. The listed applicant is Mumtaz I. Malik. The 510(k) number is K901289.

When did RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS receive FDA 510(k) clearance?

RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS received FDA 510(k) clearance on 1990-09-28, under 510(k) number K901289.

Who is the listed applicant for RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS?

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

What is the FDA product code for RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS?

The FDA product code for RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS is LXH.

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Other records listing Mumtaz I. Malik 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.

K901521OSTEOTOMES OF VARIOUS TYPESK901420VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8K901511CHISEL, BONE, SURGICALK8939024 X 4 STERILE GAUZE SPONGE TRAYK890071STERILE LACERATION TRAYK884195GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)

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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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