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FDA 510(k)

ALPHATEC CANNULATED BONE SCREWS

K-Number: K914004 · 1991-12-05

ApplicantAlphatec Mfg., Inc.
Decision Date1991-12-05
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ALPHATEC CANNULATED BONE SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Alphatec Mfg., Inc.. It received FDA 510(k) clearance on 1991-12-05 under 510(k) number K914004. 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 ALPHATEC CANNULATED BONE SCREWS?

ALPHATEC CANNULATED BONE SCREWS is a medical device that received FDA 510(k) clearance on 1991-12-05. The listed applicant is Alphatec Mfg., Inc.. The 510(k) number is K914004.

When did ALPHATEC CANNULATED BONE SCREWS receive FDA 510(k) clearance?

ALPHATEC CANNULATED BONE SCREWS received FDA 510(k) clearance on 1991-12-05, under 510(k) number K914004.

Who is the listed applicant for ALPHATEC CANNULATED BONE SCREWS?

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

What is the FDA product code for ALPHATEC CANNULATED BONE SCREWS?

The FDA product code for ALPHATEC CANNULATED BONE SCREWS is HWC. This falls under the Cardiovascular category.

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Other records listing Alphatec Mfg., Inc. as applicant

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K033090ICON POLYAXIAL PEDICLE SCREW SYSTEMK023299ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK020356ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEMK993513DELTALOC ANTERIOR CERVICAL PLATE SYSTEMK993873ALPHATEC EXTERNAL FIXATION SYSTEM COMPRESSION/DISTRACTION RODK992350PYLON INTRAMEDULLAARY NAIL SYSTEM

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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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