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FDA 510(k)

SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM

K-Number: K031609 · 2003-06-09

ApplicantSwiss Orthopedic Solutions, Inc.
Decision Date2003-06-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Swiss Orthopedic Solutions, Inc.. It received FDA 510(k) clearance on 2003-06-09 under 510(k) number K031609. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM?

SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2003-06-09. The listed applicant is Swiss Orthopedic Solutions, Inc.. The 510(k) number is K031609.

When did SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM receive FDA 510(k) clearance?

SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM received FDA 510(k) clearance on 2003-06-09, under 510(k) number K031609.

Who is the listed applicant for SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM?

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

What is the FDA product code for SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM?

The FDA product code for SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM is HRS.

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Related Devices (Code: HRS)

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.

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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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