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FDA 510(k)

ACE 3.5MM CORTICAL BONE SCREW

K-Number: K905048 · 1991-01-30

ApplicantAce Medical Co.
Decision Date1991-01-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACE 3.5MM CORTICAL BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical Co.. It received FDA 510(k) clearance on 1991-01-30 under 510(k) number K905048. 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.

Frequently Asked Questions

What is the ACE 3.5MM CORTICAL BONE SCREW?

ACE 3.5MM CORTICAL BONE SCREW is a medical device that received FDA 510(k) clearance on 1991-01-30. The listed applicant is Ace Medical Co.. The 510(k) number is K905048.

When did ACE 3.5MM CORTICAL BONE SCREW receive FDA 510(k) clearance?

ACE 3.5MM CORTICAL BONE SCREW received FDA 510(k) clearance on 1991-01-30, under 510(k) number K905048.

Who is the listed applicant for ACE 3.5MM CORTICAL BONE SCREW?

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

What is the FDA product code for ACE 3.5MM CORTICAL BONE SCREW?

The FDA product code for ACE 3.5MM CORTICAL BONE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Ace Medical Co. 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.

K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILK955472ACE HUMERUS & RADIUS PLATESK955388ACE-DUPONT COMPOSITE RINGSK9544856.5MM SOLID CANCELLOUS BONE SCREWK954069ACE CERVICAL TRACTION HALOZS, TONGS & PINSK950618ACE SUPRACONDYLAR PLATE

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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.

K262975Arthrex Beaming SystemArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large Compression ScrewsTriMed, Inc.

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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