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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 8 of 208

Device	Model / Reference	Registries	Class	Status
Snap-Off Screw System	410-25330	FDA UDI	Class II	Active
Fps	M25-351013	FDA UDI	Class II	Active
Tyber Medical	302-P3012010-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770240021	FDA UDI	Class II	Active
Tyber Medical	502-P3017012-S	FDA UDI	Class II	Active
Headless Screw System	401-15420	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76317056SH	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø4.5mm x 60mm	FDA UDI	Class II	Unknown
Orion Headed Screw	HTR-04-654185	FDA UDI	Class II	Active
Snap-Off Screw System	410-30231	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76337046FT	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB80280	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB50330	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø4.5mm x 85mm	FDA UDI	Class II	Unknown
Leos	7621-2728	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-454500	FDA UDI	Class II	Active
Tyber Medical	Headless Ø3.0 x 15mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770604090	EUDAMEDFDA UDI	Class II	Active
P-tanium TLIF	TPT-T3011502-S	FDA UDI	Class II	Active
Fps	F25-011022	FDA UDI	Class I	Active
A.L.P.S. mvX™	770200006	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 27mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Short Ø6.5mm x 48mm	FDA UDI	Class II	Unknown
Tyber Medical	502-P2612812-S	FDA UDI	Class II	Active
Tyber Medical	302-T2611523-S	FDA UDI	Class II	Active
Leos	7622-0350	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-301209-0	FDA UDI	Class II	Active
TPLIF Interbody System	M2-P2414010-S	FDA UDI	Class II	Active
Tyber Medical	502-P26808-S	FDA UDI	Class II	Active
Tyber Medical	302-P241388-S	FDA UDI	Class II	Active
Hermes TyPEEK Curve Cage	HRM-T2612023-S	FDA UDI	Class II	Active
Riptide	6ZBZC1504	FDA UDI	Class II	Active
Tyber Medical	502-P329210-S	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843710	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40375	FDA UDI	Class II	Active
Tyber Medical	002-P321208	FDA UDI	Class II	Active
A.L.P.S. mvX™	770718621	EUDAMEDFDA UDI	Class II	Active
A.L.P.S. mvX™	770270010	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 16mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	502-P229012-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	880450050S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40442	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 28mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	Headless Ø1.5 x 9mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Snap-Off Screw System	410-25416	FDA UDI	Class II	Active
Cannulated Screw System +	04.353.814	FDA UDI	Class II	Active
Tyber Medical	502-P2610012-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770351040	FDA UDI	Class II	Active
Tyber Medical	502-P2217010-S	FDA UDI	Class II	Active
Tyber Medical	302-P2416012-S	FDA UDI	Class II	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