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FDA 510(k)

BONE PAD REMOVER

K-Number: K910225 · 1991-02-12

ApplicantAcra Cut, Inc.
Decision Date1991-02-12
Product CodeHAO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BONE PAD REMOVER is the device name listed in this FDA 510(k) record. The listed applicant is Acra Cut, Inc.. It received FDA 510(k) clearance on 1991-02-12 under 510(k) number K910225. The device is classified under product code HAO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE PAD REMOVER?

BONE PAD REMOVER is a medical device that received FDA 510(k) clearance on 1991-02-12. The listed applicant is Acra Cut, Inc.. The 510(k) number is K910225.

When did BONE PAD REMOVER receive FDA 510(k) clearance?

BONE PAD REMOVER received FDA 510(k) clearance on 1991-02-12, under 510(k) number K910225.

Who is the listed applicant for BONE PAD REMOVER?

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

What is the FDA product code for BONE PAD REMOVER?

The FDA product code for BONE PAD REMOVER is HAO.

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Other records listing Acra Cut, Inc. 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.

K032970ACRA-CUT XPRESS 120K944311ACRA-CUTK911812ACRA-CUT WIRE PASS DRILLK911819ACRA-CUT NEUROLOGICAL SURGICAL DEVICE-POWEREDK910226DURAL DISSECTORSK892866AUTOMATIC CRANIAL DRILL (PERFORATOR)

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Related Devices (Code: HAO)

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.

K220920Matreneu Percutaneous Balloon Compression KitShenzhen Shineyard Medical Device Co. , Ltd.K940973MULLAN GANGLION MICROCOMPRESSION SETCook, Inc.K951492RIB RESECTORUnited States Surgical, A Division of Tyco HealthcK943115AUTO SUTURE PITUITARY SPINAL RONGEURUnited States Surgical, A Division of Tyco HealthcK942967AUTO SUTURE SPINAL CURETTEUnited States Surgical, A Division of Tyco HealthcK942969AUTO SUTURE SPINAL NERVE HOOKUnited States Surgical, A Division of Tyco Healthc

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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