FDA 510(k)

MODEL 28200C MICRO-ARTHROPLASTY SYSTEM

K-Number: K871717 · 1987-06-05

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1987-06-05

Product CodeHWE

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

MODEL 28200C MICRO-ARTHROPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1987-06-05 under 510(k) number K871717. The device is classified under product code HWE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 28200C MICRO-ARTHROPLASTY SYSTEM?

MODEL 28200C MICRO-ARTHROPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 1987-06-05. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K871717.

When did MODEL 28200C MICRO-ARTHROPLASTY SYSTEM receive FDA 510(k) clearance?

MODEL 28200C MICRO-ARTHROPLASTY SYSTEM received FDA 510(k) clearance on 1987-06-05, under 510(k) number K871717.

Who is the listed applicant for MODEL 28200C MICRO-ARTHROPLASTY SYSTEM?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 28200C MICRO-ARTHROPLASTY SYSTEM?

The FDA product code for MODEL 28200C MICRO-ARTHROPLASTY SYSTEM is HWE.

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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.