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Data / Medical devices / Netherlands / Baat Medical Products B.V.

Baat Medical Products B.V.: FDA-registered device maker in Hengelo Overijssel, Netherlands, 6 510(k) clearances

Baat Medical Products B.V. is registered with the FDA (registration 3015216945) in Hengelo Overijssel, Netherlands. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 16, 2026. Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this oneWatch Baat Medical Products B.V.
FDA registration number
3015216945
Address
F. Hazemeijerstraat 800, Hengelo Overijssel, Netherlands, 7555 RJ
Owner or operator
Baat Medical Products B.V. (10062076)
Roles
Contract manufacturer, Specification developer
First device listed
December 16, 2019
Registered through
2027
Brand names listed
ANSER Clavicle Pin, FAVO S-TLIF-Cage, Fortilink Cages with TiPlus technology, Kleiner KG2 System, Oyster ACIF Cage, Oyster ACIF Trial, SDS Growing Rod, SINEFIX and more

Devices it lists

DeviceProduct codeClassRoleSource
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Growing Rod SystemPGM2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Contract manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufacturer, Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Specification developeraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Specification developeraccessdata.fda.gov
Pin, Fixation, ThreadedJDW2Specification developeraccessdata.fda.gov
ProbeHXB1Contract manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 16, 2026K254176SINEFIXMBISubstantially EquivalentBAAT Medical Products B.V.accessdata.fda.gov
January 15, 2026K251961SDS Growing RodPGMSubstantially EquivalentBAAT Medical Products B.V.accessdata.fda.gov
March 8, 2023K220966SINEFIXMBISubstantially EquivalentBAAT Medical Products B.V.accessdata.fda.gov
September 14, 2021K211474Kleiner KG2 SystemMAXSubstantially EquivalentBAAT Medical Products B.V.accessdata.fda.gov
October 7, 2020K201453Fortilink Cages with TiPlus TechnologyMAXSubstantially EquivalentParadigm Spine GmbHaccessdata.fda.gov
August 27, 2020K201830ANSER Clavicle PinHSBSubstantially EquivalentBAAT Medical Products B.V.accessdata.fda.gov

Compare with other makers

Updated March 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.