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FDA 510(k)

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES

K-Number: K102743 · 2011-01-20

ApplicantOrtho Solutions Limited
Decision Date2011-01-20
Product CodeHWE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES 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 2011-01-20 under 510(k) number K102743. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES?

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES is a medical device that received FDA 510(k) clearance on 2011-01-20. The listed applicant is Ortho Solutions Limited. The 510(k) number is K102743.

When did ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES receive FDA 510(k) clearance?

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES received FDA 510(k) clearance on 2011-01-20, under 510(k) number K102743.

Who is the listed applicant for ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES?

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 - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES?

The FDA product code for ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES is HWE.

Related Clinical Trials

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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 OSTEOSYSNTHESISK110895ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS

Related Devices (Code: HWE)

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.

K063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer TrabecularK043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device ServicesK012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven MedicalK012676REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPSAdven Medical

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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