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FDA 510(k)

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

K-Number: K010051 · 2001-07-13

ApplicantXiros Plc
Decision Date2001-07-13
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Xiros Plc. It received FDA 510(k) clearance on 2001-07-13 under 510(k) number K010051. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY-TAPES WITH THE FASTLOK FIXATION DEVICE?

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2001-07-13. The listed applicant is Xiros Plc. The 510(k) number is K010051.

When did POLY-TAPES WITH THE FASTLOK FIXATION DEVICE receive FDA 510(k) clearance?

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE received FDA 510(k) clearance on 2001-07-13, under 510(k) number K010051.

Who is the listed applicant for POLY-TAPES WITH THE FASTLOK FIXATION DEVICE?

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

What is the FDA product code for POLY-TAPES WITH THE FASTLOK FIXATION DEVICE?

The FDA product code for POLY-TAPES WITH THE FASTLOK FIXATION DEVICE is JDR.

Related Clinical Trials

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.

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Other records listing Xiros Plc 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.

K002172POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

Related Devices (Code: JDR)

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.

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Official Source

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