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FDA 510(k)

CORTICAL BONE SCREW

K-Number: K942340 · 1994-12-05

ApplicantAcu Med, Inc.
Decision Date1994-12-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

CORTICAL BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1994-12-05 under 510(k) number K942340. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the CORTICAL BONE SCREW?

CORTICAL BONE SCREW is a medical device that received FDA 510(k) clearance on 1994-12-05. The listed applicant is Acu Med, Inc.. The 510(k) number is K942340.

When did CORTICAL BONE SCREW receive FDA 510(k) clearance?

CORTICAL BONE SCREW received FDA 510(k) clearance on 1994-12-05, under 510(k) number K942340.

Who is the listed applicant for CORTICAL BONE SCREW?

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

What is the FDA product code for CORTICAL BONE SCREW?

The FDA product code for CORTICAL BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Acu Med, 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.

K021321WRIST FUSION PLATEK013616POLARUS CAP SCREWK012655CONGRUENT BONE PLATE SYSTEMK992525ACUMED MODULAR SHOULDER SYSTEMK993657ACUMED SUTURE ANCHORK980103ACUMED SUTURE ANCHOR

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Related Devices (Code: HWC)

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.

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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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