Polybone Granule & Block

FDA 510(k) K082338 · Kyung Won Medical Co., Ltd.

Substantially Equivalent

510(k) numberK082338

Submission

Device name
Polybone Granule & Block
Applicant
Kyung Won Medical Co., Ltd.
Santa Fe Springs, CA, US
Received
August 14, 2008
Decision date
October 16, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQV – Filler, Bone Void, Calcium Compound
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3045
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Polybone Granule & Block cleared by the FDA?

Polybone Granule & Block (K082338) received a 510(k) decision of Substantially Equivalent on October 16, 2008, 63 days after the submission was received.

What is the product code of K082338?

The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.