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FDA 510(k)

LOGYK ACETABULAR COMPONENT SYSTEM

K-Number: K931107 · 1994-03-28

ApplicantArthronics, Inc.
Decision Date1994-03-28
Product CodeMBL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LOGYK ACETABULAR COMPONENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthronics, Inc.. It received FDA 510(k) clearance on 1994-03-28 under 510(k) number K931107. The device is classified under product code MBL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOGYK ACETABULAR COMPONENT SYSTEM?

LOGYK ACETABULAR COMPONENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-28. The listed applicant is Arthronics, Inc.. The 510(k) number is K931107.

When did LOGYK ACETABULAR COMPONENT SYSTEM receive FDA 510(k) clearance?

LOGYK ACETABULAR COMPONENT SYSTEM received FDA 510(k) clearance on 1994-03-28, under 510(k) number K931107.

Who is the listed applicant for LOGYK ACETABULAR COMPONENT SYSTEM?

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

What is the FDA product code for LOGYK ACETABULAR COMPONENT SYSTEM?

The FDA product code for LOGYK ACETABULAR COMPONENT SYSTEM is MBL.

Related Clinical Trials

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Other records listing Arthronics, Inc. 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.

K921382FUTURA TEXTURE-TRAKKED TOTAL HIP STEM

Related Devices (Code: MBL)

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.

K201157Prime BIOFOAM® Multi-Hole ShellsMicroport Orthopedics, Inc.K201701R3 HA Coated Acetabular ShellsSmith & Nephew, Inc.K182535R3 Anteverted LinersSmith & Nephew, Inc.K161233OXINIUM DH Fermoral HeadsSmith & Nephew, Inc.K122382DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113848R3 XLPE LINERSSmith & Nephew, Inc.

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.

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