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FDA 510(k)

IP-XS COMPRESSION NAIL SYSTEM

K-Number: K032548 · 2003-09-10

ApplicantPlus Orthopedics
Decision Date2003-09-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IP-XS COMPRESSION NAIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Plus Orthopedics. It received FDA 510(k) clearance on 2003-09-10 under 510(k) number K032548. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IP-XS COMPRESSION NAIL SYSTEM?

IP-XS COMPRESSION NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-10. The listed applicant is Plus Orthopedics. The 510(k) number is K032548.

When did IP-XS COMPRESSION NAIL SYSTEM receive FDA 510(k) clearance?

IP-XS COMPRESSION NAIL SYSTEM received FDA 510(k) clearance on 2003-09-10, under 510(k) number K032548.

Who is the listed applicant for IP-XS COMPRESSION NAIL SYSTEM?

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

What is the FDA product code for IP-XS COMPRESSION NAIL SYSTEM?

The FDA product code for IP-XS COMPRESSION NAIL SYSTEM is HSB.

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Other records listing Plus Orthopedics 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.

K032126PROMOS SHOULDERK033763MODIFICATION TO SLIM GLIDING NAIL SYSTEMK032709MODULAR PLUS HIP STEMK032215VKS/TC-PLUS REVISION KNEEK032052UC-PLUS SOLUTION UNICONDYLAR KNEEK031165PLUS ORTHOPEDICS CEMENTED HIP STEM

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Related Devices (Code: HSB)

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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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