Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015216945

FEI Number

3015216945

Entity Name

BAAT MEDICAL PRODUCTS B.V.

City/State/Country

Hengelo Overijssel, NL

Establishment Address

F. Hazemeijerstraat 800, Hengelo Overijssel 7555 RJ, NL

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Baat Medical Products B.V. (Owner Number: 10062076)

Owner / Operator Contact Address

F. Hazemeijerstraat 800, Hengelo, NL-OV 7555 RJ, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Fortilink Cages with TiPlus technology SDS Growing Rod Oyster ACIF Trial FAVO S-TLIF-Cage ANSER Clavicle Pin Oyster ACIF Cage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2021-10-11
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2021-10-11
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2021-10-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-10-11
PGM	Growing Rod System	Orthopedic	Class 2	888.3070	2026-01-22
HXB	Probe	Orthopedic	Class 1	888.4540	2019-12-16
PHM	Intervertebral Fusion Device With Bone Graft, Thoracic	Orthopedic	Class 2	888.3080	2020-01-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2020-01-20
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2020-09-09
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2020-09-09
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-12-16

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

Baat Medical Products B.V.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K192492	Astura Medical, LLC	EL CAPITAN Anterior Lumber Interbody System	2020-04-21
K212498	Nexus Spine, LLC	Stable-L Standalone Lumbar Interbody System	2022-03-18
K142269	Reliance Medical Systems, LLC	Reliance Cervical IBF System	2015-06-09
K122085	Omni Surgical, LP Dba Spine360	STINGRAY CERVICAL CAGE	2012-10-17
K120275	Synthes (Usa), LLC	SYNTHES ACIS/VERTEBRAL SPACER CR	2012-05-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015216945. Last updated year: 2026. Please use registration number 3015216945 when referencing this establishment in official correspondence.