FDA 510(k)

PF2

K-Number: K012062 · 2001-09-27

Decision Date2001-09-27

Product CodeKTT

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PF2 is the device name listed in this FDA 510(k) record. The listed applicant is Fixano SA. It received FDA 510(k) clearance on 2001-09-27 under 510(k) number K012062. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PF2?

PF2 is a medical device that received FDA 510(k) clearance on 2001-09-27. The listed applicant is Fixano SA. The 510(k) number is K012062.

When did PF2 receive FDA 510(k) clearance?

PF2 received FDA 510(k) clearance on 2001-09-27, under 510(k) number K012062.

Who is the listed applicant for PF2?

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

What is the FDA product code for PF2?

The FDA product code for PF2 is KTT.

Other records listing Fixano SA 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.

K023314MICROFIX K022771TWIN FIX K012078RADIOFIX K012161FLEX-NAILS

Related Devices (Code: KTT)

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC K260900DYNEX® External Fixation SystemsVilex, LLC K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean Global K253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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.