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FDA 510(k)

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

K-Number: K110895 · 2011-12-19

ApplicantOrtho Solutions Limited
Decision Date2011-12-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Solutions Limited. It received FDA 510(k) clearance on 2011-12-19 under 510(k) number K110895. 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 ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS?

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS is a medical device that received FDA 510(k) clearance on 2011-12-19. The listed applicant is Ortho Solutions Limited. The 510(k) number is K110895.

When did ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS receive FDA 510(k) clearance?

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS received FDA 510(k) clearance on 2011-12-19, under 510(k) number K110895.

Who is the listed applicant for ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS?

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

What is the FDA product code for ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS?

The FDA product code for ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS is HWC. This falls under the Cardiovascular category.

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Other records listing Ortho Solutions Limited 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.

K121575OXFORD ANKLE FUSION NAIL(AFN) SYSTEMK120360ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESISK111678ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISK102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

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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