510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K071937Substantially Equivalent

Bonalive Granules and Bonalive Plates

Vivoxid, Ltd., Findley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071937 is the FDA 510(k) clearance record for BONALIVE GRANULES AND BONALIVE PLATES, a class II device, cleared for Vivoxid , Ltd. on under FDA product code KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction). FDA records list 3 510(k) clearances for Vivoxid , Ltd., from to . As of , FDA records show no recalls naming K071937.

Clearance record

Decision date
Received
(98 days to decision)
Product code
KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Regulation
21 CFR 878.3500
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Vivoxid , Ltd. 6470 Riverview Ter., Findley MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KKY

Trailing 12 months

FDA records hold no clearances under product code KKY in the trailing twelve months.

FDA records show no clearances under product code KKY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KKY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260