Orhtopedic Reamer 87 HTD

FDA 510(k) K802676 · Zimmer, Inc.

Substantially Equivalent

510(k) numberK802676

Submission

Device name
Orhtopedic Reamer 87 HTD
Applicant
Zimmer, Inc.
Mchenry, IL, US
Received
October 29, 1980
Decision date
November 12, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTD – Forceps
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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Questions and answers

When was Orhtopedic Reamer 87 HTD cleared by the FDA?

Orhtopedic Reamer 87 HTD (K802676) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 14 days after the submission was received.

What is the product code of K802676?

The FDA product code is HTD – Forceps, a Class I (low risk) device regulated under 21 CFR 878.4800.