FDA 510(k)

PL8 Wrist Reconstruction Plate

K-Number: K180150 · 2018-08-02

Decision Date2018-08-02

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PL8 Wrist Reconstruction Plate is the device name listed in this FDA 510(k) record. The listed applicant is Citieffe S.R.L.. It received FDA 510(k) clearance on 2018-08-02 under 510(k) 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. The listed applicant is Citieffe S.R.L.. The 510(k) number is K180150.

When did PL8 Wrist Reconstruction Plate receive FDA 510(k) clearance?

PL8 Wrist Reconstruction Plate received FDA 510(k) clearance on 2018-08-02, under 510(k) number K180150.

Who is the listed applicant for PL8 Wrist Reconstruction Plate?

The FDA 510(k) record lists Citieffe S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PL8 Wrist Reconstruction Plate?

The FDA product code for PL8 Wrist Reconstruction Plate is HRS.

Other records listing Citieffe S.R.L. 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.

K250197Estremo Fibular Nail K183666EBA One Nailing System K181540Estremo Citieffe Nailing System K163323Dolphix® External Fixation System MR Conditional

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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.