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FDA 510(k)

CHISEL, BONE, SURGICAL

K-Number: K901511 · 1990-09-28

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

Device Summary

CHISEL, BONE, SURGICAL 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 K901511. 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 CHISEL, BONE, SURGICAL?

CHISEL, BONE, SURGICAL 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 K901511.

When did CHISEL, BONE, SURGICAL receive FDA 510(k) clearance?

CHISEL, BONE, SURGICAL received FDA 510(k) clearance on 1990-09-28, under 510(k) number K901511.

Who is the listed applicant for CHISEL, BONE, SURGICAL?

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 CHISEL, BONE, SURGICAL?

The FDA product code for CHISEL, BONE, SURGICAL 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.

K901289RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTSK901521OSTEOTOMES OF VARIOUS TYPESK901420VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8K8939024 X 4 STERILE GAUZE SPONGE TRAYK890071STERILE LACERATION TRAYK884195GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES)

View all 7 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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