510(k) clearances

GANNET®

BAAT Medical Products B.V. · Orthopedic

K262184Substantially EquivalentTraditionalJDO
Open FDA's page for this record
Third party flag
N
City
Hengelo
Advisory committee description
Orthopedic
Address 1
F. Hazemeijerstraat 800
Address 2
Bldg. A04
Statement or summary
Summary
Product code
JDO
Zip code
7555RJ
Applicant
BAAT Medical Products B.V.
Decision date
2026-10-22
Decision code
SESE
Country code
NL
Device name
GANNET®
Advisory committee
OR
Contact
Jasper Springer
K number
K262184
Date received
2026-06-29
Review advisory committee
OR
Postal code
7555RJ
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Device, Fixation, Proximal Femoral, Implant
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
1526534, 3004188066, 3004142400, 3036756245, 3008868758, 3034676720, 3021008900, 3011656326, 3022142628, 3003541440, 1643264, 3009973505, 3011500362, 3015207155, 3007366790, 3010120135, 3005061536, 3007993775, 1020279, 3006460162, 3014129047, 9680825, 3009826895, 1000550978, 3009887475, 9613369, 1825034, 3030412764, 3013055499, 3009959868, 3038503932, 2249615, 3009973336, 3015399803, 2134947, 3015440604, 3035366890, 3033509898, 3008812560, 3006017180 +20 more
FEI number
1526534, 3004188066, 3004142400, 3036756245, 3008868758, 3034676720, 3021008900, 3011656326, 3022142628, 3003541440, 1643264, 3009973505, 3011500362, 3015207155, 3002807827, 3010120135, 3019827409, 3000205591, 1000115656, 3007993775, 1020279, 3006460162, 3009826895, 1000550978, 3007282753, 3009887475, 1000306431, 1825034, 3030412764, 3001049282, 3013055499, 3009959868, 3038503932, 3009973336, 3015399803, 3015440604, 3035366890, 3033509898, 3008812560, 3006017180 +20 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.