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FDA 510(k)

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732

K-Number: K041117 · 2004-05-28

ApplicantDepuy Mitek
Decision Date2004-05-28
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek. It received FDA 510(k) clearance on 2004-05-28 under 510(k) number K041117. 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 PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732?

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 is a medical device that received FDA 510(k) clearance on 2004-05-28. The listed applicant is Depuy Mitek. The 510(k) number is K041117.

When did PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 receive FDA 510(k) clearance?

PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 received FDA 510(k) clearance on 2004-05-28, under 510(k) number K041117.

Who is the listed applicant for PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732?

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

What is the FDA product code for PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732?

The FDA product code for PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 is JDR.

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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.

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