510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bone Index Finland Ltd.

Kuopio Pohjois-Savo, FI

BONE INDEX FINLAND LTD. appears in FDA device records in Kuopio Pohjois-Savo, FI. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Bone Index Finland Ltd. between 2016 and 2022. The busiest year on record is 2016, with 1. The most recent is 2022, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bone Index Finland Ltd., by decision year
YearClearances
20161
20171
20221
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K211350Bindex BI-2MUASubstantially Equivalent
K161971Bindex BI-2MUASubstantially Equivalent
K152020Bindex BI-100MUASubstantially Equivalent

Registered establishments

FDA registered establishments for Bone Index Finland Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30133288803013328880BONE INDEX FINLAND LTD.Savilahdentie 14, Kuopio Pohjois-Savo 70700 FI2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain