Phoenix Burr Hole Button, Burr 1

FDA 510(k) K913490 · Phoenix Bioengineering, Inc.

Substantially Equivalent

510(k) numberK913490

Submission

Device name
Phoenix Burr Hole Button, Burr 1
Applicant
Phoenix Bioengineering, Inc.
Bridgeport, PA, US
Received
August 6, 1991
Decision date
January 13, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GXR – Cover, Burr Hole
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5250
Specialty
Neurology
Implant
Yes

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K221606Absorbable Cranial Flap Fixation SystemGXR · Traditional Chendu Medart Medical Scientific Co., Ltd.11/21/2023SE
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K181539OSSDSIGN CranioplugGXR · Traditional Ossdsign AB10/12/2018SE
K181382GuardianTM Burr Hole Cover SystemGXR · Abbreviated St Jude Medical07/20/2018SE
K160739Cranial COVERGXR · Traditional Neos Surgery S.L06/12/2016SE
K152342Guardian Burr Hole Cover System, Guardian Screw, Burr Hole CoverGXR · Traditional St Jude Medical06/09/2016SE
K140309CranioplugGXR · Traditional Ossdsign AB10/03/2014SE

More from Ossdsign AB

510(k)DeviceDecision
K930125Phoenix Bone Screws Pbs-Type SeriesHXA · Traditional 12/30/1993SE
K904434Sexton Cystotomy Urine Pump (SCUP2)KOB · Traditional 02/01/1991SE

Questions and answers

When was Phoenix Burr Hole Button, Burr 1 cleared by the FDA?

Phoenix Burr Hole Button, Burr 1 (K913490) received a 510(k) decision of Substantially Equivalent on January 13, 1992, 160 days after the submission was received.

What is the product code of K913490?

The FDA product code is GXR – Cover, Burr Hole, a Class II (moderate risk) device regulated under 21 CFR 882.5250.