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Tyber Medical

United States·US-MF-000011350

Last updated September 17, 2026

Information

Country: United States
Address: 83, South Commerce Way, Bethlehem, United States
Website: tybermedical.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 866-761-0933
PRRC Contact: Lisa Boyle
EUDAMED SRN: US-MF-000011350
FDA FEI Number: 3017980495
DUNS Number: —

Catalogue (10381)

Page 1 of 208

Device	Model / Reference	Registries	Class	Status
Titanium Alloy Wrist Plates	04.426.751	EUDAMED	Class IIb	Active
Titanium Alloy Wrist Plates	04.426.750S	EUDAMED	Class IIb	Active
Stainless Steel Wrist Plates	02.426.521S	EUDAMED	Class IIb	Active
Instrumentation	770101090	EUDAMED	Class I	Active
Navigated LLIF Impactable Tracker	K261060	FDA 510(k)	Class II	Active
Tyber Medical	502-P2216010-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770130007	EUDAMEDFDA UDI	Class II	Active
Snap-Off Screw System	410-25229	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P2212810-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	03.333.005	FDA UDI	Class I	Active
Focus TyPEEK	SV2614P	FDA UDI	Class II	Active
A.L.P.S. mvX™	770200019	EUDAMEDFDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-301212-0	FDA UDI	Class II	Active
TPLIF Interbody System	M2-T2612523-S	FDA UDI	Class II	Active
Tyber Medical	Fixed Screws 4.25 mm OD x 15 mm	FDA UDI	Class II	Active
Snap-Off Screw System	410-15219	FDA UDI	Class II	Active
Tyber Medical	502-P3012012-S	FDA UDI	Class II	Active
Tyber Medical	302-P2412012-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB80475	FDA UDI	Class II	Active
Tyber Medical	502-P221008-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 12mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770240012	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 16mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø6.5 x 36mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	PLIF 26mm x 12mm x 9mm x 0 degree	FDA UDI	Class II	Active
Tyber Medical	502-P2211012-S	FDA UDI	Class II	Active
Tyber Medical	502-T2612023-S	FDA UDI	Class II	Active
Headed Screw System	9ZB25245	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188823208	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40436	FDA UDI	Class II	Active
Fps	FGC-00008	FDA UDI	Class I	Active
Tyber Medical	502-P2217812-S	FDA UDI	Class II	Active
Tyber Medical	302-P2617810-S	FDA UDI	Class II	Active
ACIF Interbody System	M2-C14555-S	FDA UDI	Class II	Active
Battalion Lateral Plate System Instruments	27500-0405	FDA UDI	Class I	Active
CONCORDE® ProTi 360°™	188823408	FDA UDI	Class II	Active
Fps	F25-008015	FDA UDI	Class I	Active
A.L.P.S. mvX™	770707090	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	302-P2612812-S	FDA UDI	Class II	Active
CONCORDE® ProTi 360°™	188827514	FDA UDI	Class II	Active
ACIF Interbody System	M2-C141205-S	FDA UDI	Class II	Active
Fps	M25-201026	FDA UDI	Class II	Active
Headless Screw System	401-20334	FDA UDI	Class II	Active
Tyber Medical	502-P2211010-S	FDA UDI	Class II	Active
T-PAL™ ProTi 360°™	108812009	FDA UDI	Class II	Active
Fps	M25-351040	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76308544	FDA UDI	Class I	Active
Fps	M25-714021	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-654580	FDA UDI	Class II	Active
1.5 / 2.0 / 3.0 Trauma Screw Tray Instruments	001-120116	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

MDSS GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 19, 2025	Z-1131-2026	—	open, classified	The supplier manufactured anatomical left plates with an incorrect thread orientation.
Dec 19, 2025	Z-1132-2026	—	open, classified	The supplier manufactured anatomical left plates with an incorrect thread orientation.
Jan 21, 2025	Z-1214-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1209-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1223-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1226-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1211-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1225-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1216-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1213-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1224-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1210-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1219-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1217-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1218-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1222-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1220-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1212-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1215-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
Jan 21, 2025	Z-1221-2025	—	open, classified	Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices