Laminectomy Rongeur

FDA 510(k) K901372 · Zeppelin GmbH

Substantially Equivalent

510(k) numberK901372

Submission

Device name
Laminectomy Rongeur
Applicant
Zeppelin GmbH
West Germany, DE
Received
March 22, 1990
Decision date
June 28, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAE – Rongeur, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4840
Specialty
Neurology

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K180949SteribiteHAE · Traditional Rjr Surgical, Inc.11/08/2018SE
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More from Symmetry Surgical, Inc.

510(k)DeviceDecision
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Questions and answers

When was Laminectomy Rongeur cleared by the FDA?

Laminectomy Rongeur (K901372) received a 510(k) decision of Substantially Equivalent on June 28, 1990, 98 days after the submission was received.

What is the product code of K901372?

The FDA product code is HAE – Rongeur, Manual, a Class II (moderate risk) device regulated under 21 CFR 882.4840.