PL8 Wrist Reconstruction Plate
K-Number: K180150 · 2018-08-02
ApplicantCitieffe S.R.L.
Decision Date2018-08-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PL8 Wrist Reconstruction Plate is a medical device manufactured by Citieffe S.R.L.. It received FDA 510(k) clearance on 2018-08-02 under approval number K180150. 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 PL8 Wrist Reconstruction Plate?
PL8 Wrist Reconstruction Plate is a medical device that received FDA 510(k) clearance on 2018-08-02. It is manufactured by Citieffe S.R.L.. The 510(k) number is K180150.
When was PL8 Wrist Reconstruction Plate approved by the FDA?
PL8 Wrist Reconstruction Plate received FDA 510(k) clearance on 2018-08-02, under approval number K180150.
What company makes PL8 Wrist Reconstruction Plate?
PL8 Wrist Reconstruction Plate is manufactured by Citieffe S.R.L..
What is the FDA product code for PL8 Wrist Reconstruction Plate?
The FDA product code for PL8 Wrist Reconstruction Plate is HRS.
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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.