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FDA 510(k)

SELF-COUNTERSINKING BONE SCREW

K-Number: K013534 · 2001-12-17

ApplicantBiomet Orthopedics, Inc.
Decision Date2001-12-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SELF-COUNTERSINKING BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-12-17 under 510(k) number K013534. 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 SELF-COUNTERSINKING BONE SCREW?

SELF-COUNTERSINKING BONE SCREW is a medical device that received FDA 510(k) clearance on 2001-12-17. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K013534.

When did SELF-COUNTERSINKING BONE SCREW receive FDA 510(k) clearance?

SELF-COUNTERSINKING BONE SCREW received FDA 510(k) clearance on 2001-12-17, under 510(k) number K013534.

Who is the listed applicant for SELF-COUNTERSINKING BONE SCREW?

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

What is the FDA product code for SELF-COUNTERSINKING BONE SCREW?

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

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Other records listing Biomet Orthopedics, 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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsK080528E-POLY TIBIAL BEARINGSK072879INNERVUE DIAGNOSTIC SCOPE SYSTEMK070955ACID ETCHED LAG SCREWSK033355LACTOSCREW SCREW ANCHORK032286CALCIGEN PSI BONE GRAFT SUBSTITUTE

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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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