Aneuroplastic, Model 43-1290

FDA 510(k) K071776 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK071776

Submission

Device name
Aneuroplastic, Model 43-1290
Applicant
Codman & Shurtleff, Inc.
Raynham, MA, US
Received
June 29, 2007
Decision date
July 26, 2007
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JXH – Methyl Methacrylate For Aneurysmorrhaphy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5030
Specialty
Neurology
Implant
Yes

Other 510(k)s with product code JXH

510(k)DeviceApplicantDecision
K882072Orthopaedic and Spinal Ring CurrettesJXH · Traditional Karlin Technology, Inc.06/17/1988SE
K873688Aneuroplastic, Acrylic Aneuryomorrhaply MaterialJXH · Traditional Dentsply Intl.10/26/1987SE

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Questions and answers

When was Aneuroplastic, Model 43-1290 cleared by the FDA?

Aneuroplastic, Model 43-1290 (K071776) received a 510(k) decision of Substantially Equivalent on July 26, 2007, 27 days after the submission was received.

What is the product code of K071776?

The FDA product code is JXH – Methyl Methacrylate For Aneurysmorrhaphy, a Class II (moderate risk) device regulated under 21 CFR 882.5030.