510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bonebridge AG

Zug, CH

BONEBRIDGE AG appears in FDA device records in Zug, CH. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. 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
10
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 10 510(k) clearances for Bonebridge AG between 2021 and 2026. The busiest year on record is 2024, with 3. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Bonebridge AG, by decision year
YearClearances
20211
20221
20231
20243
20252
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261351SALGINA 2.5mm Distal Radius SystemHRSSubstantially Equivalent
K260228POYA 3.5mm Medial Proximal Tibia SystemHRSSubstantially Equivalent
K252191BRUSIO Trauma Toolbox System; TAMINA 3.5mm Proximal Humerus SystemHRSSubstantially Equivalent
K250933LORRAINE 2.5/3.5mm Distal Humerus SystemHRSSubstantially Equivalent
K243308Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)HRSSubstantially Equivalent
K242399Bonebridge Osteosynthesis Plating SystemHRSSubstantially Equivalent
K240318SITTER 3.5mm Versatile SystemHRSSubstantially Equivalent
K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE 3.5mm Distal Humerus SystemHRSSubstantially Equivalent
K213864Bonebridge Osteosynthesis Plating SystemHRSSubstantially Equivalent
K203002SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular SystemHRSSubstantially Equivalent

Registered establishments

FDA registered establishments for Bonebridge AG, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30210102223021010222BONEBRIDGE AGBahnhofstrasse 11, ZUG 6300 CH2026and 2 more, listed in full below
30243582263024358226BONEBRIDGE INC.2125 Center Ave., Fort Lee, NJ 07024 US2026No device listings on this registration

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