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FDA 510(k)

ACUTE BONE SCREW

K-Number: K061206 · 2006-06-19

ApplicantAcute Innovations, LLC
Decision Date2006-06-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUTE BONE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Acute Innovations, LLC. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K061206. 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 ACUTE BONE SCREW?

ACUTE BONE SCREW is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Acute Innovations, LLC. The 510(k) number is K061206.

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

ACUTE BONE SCREW received FDA 510(k) clearance on 2006-06-19, under 510(k) number K061206.

Who is the listed applicant for ACUTE BONE SCREW?

The FDA 510(k) record lists Acute Innovations, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUTE BONE SCREW?

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

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Other records listing Acute Innovations, LLC 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.

K120163ACUTE INNOVATIONS BIOBRIDGE RESORBABLE PLATING SYSTEMK113318ACUTE INNOVATIONS MODULAR RIBLOC SYSTEMK101170ACUTE INNOVATIONS STERNAL FIXATION SYSTEMK081588RE-ZORB PLATING SYSTEM

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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