POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

Staple, Fixation, Bone

XIROS PLC

The following data is part of a premarket notification filed by Xiros Plc with the FDA for Poly-tapes With The Fastlok Fixation Device.

Pre-market Notification Details

Device IDK010051
510k NumberK010051
Device Name:POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
ClassificationStaple, Fixation, Bone
Applicant XIROS PLC 28-30 BLENHEIM TERRACE Leeds,  GB Ls2 9hd
ContactJim Rowland
CorrespondentJim Rowland
XIROS PLC 28-30 BLENHEIM TERRACE Leeds,  GB Ls2 9hd
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-01-08
Decision Date2001-07-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060267130587 K010051 000
05060267130365 K010051 000
05060267130372 K010051 000
05060267130389 K010051 000
05060267130402 K010051 000
05060267130433 K010051 000
05060267130471 K010051 000
05060267130488 K010051 000
05060267130495 K010051 000
05060267130501 K010051 000
05060267131812 K010051 000

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