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FDA 510(k)

PLLA CANNULATED INTERFERENCE SCREW

K-Number: K032830 · 2004-12-14

ApplicantAdvanced Biomaterials
Decision Date2004-12-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PLLA CANNULATED INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomaterials. It received FDA 510(k) clearance on 2004-12-14 under 510(k) number K032830. 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 PLLA CANNULATED INTERFERENCE SCREW?

PLLA CANNULATED INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Advanced Biomaterials. The 510(k) number is K032830.

When did PLLA CANNULATED INTERFERENCE SCREW receive FDA 510(k) clearance?

PLLA CANNULATED INTERFERENCE SCREW received FDA 510(k) clearance on 2004-12-14, under 510(k) number K032830.

Who is the listed applicant for PLLA CANNULATED INTERFERENCE SCREW?

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

What is the FDA product code for PLLA CANNULATED INTERFERENCE SCREW?

The FDA product code for PLLA CANNULATED INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Advanced Biomaterials 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.

K050468TRIABSORB COMPOSITE SCREWK033749TITANIUM CANNULATED INTERFERENCE SCREW

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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