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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 11 of 208

Device	Model / Reference	Registries	Class	Status
A.L.P.S. mvX™	770008200	FDA UDI	Class I	Active
Leos	7622-1002	FDA UDI	Class II	Active
Fps	M25-304011	FDA UDI	Class II	Active
Sterile ACIF PEEK	810-160975	FDA UDI	Class II	Active
Snap-Off Screw System	410-20324	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76343530	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76317086SH	FDA UDI	Class II	Active
Orion Ti PEEK Wedge System Instruments	HTR-04-014316	FDA UDI	Class I	Active
TiLink System Instruments	35-00000116	FDA UDI	Class I	Active
Tyber Medical	Headless Ø4.5 x 65mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø1.5 x 25mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770603100	EUDAMEDFDA UDI	Class II	Active
LEOS Cannulated Screw System	76309540	FDA UDI	Class I	Active
Tyber Medical	502-P307012-S	FDA UDI	Class II	Active
Tyber Medical	302-P307010-S	FDA UDI	Class II	Active
Tyber Medical	302-P301508-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB40252	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Short Ø6.5mm x 42mm	FDA UDI	Class II	Unknown
ACIS® ProTi 360™ HL	208843309	FDA UDI	Class II	Active
Cannulated Screw System +	04.353.780S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76308520	FDA UDI	Class I	Active
Tyber Medical	Headed Cannulated Screw Short Ø6.5mm x 50mm	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB652140	FDA UDI	Class II	Active
Tyber Medical	302-P2411010-S	FDA UDI	Class II	Active
ACIS® ProTi 360™ HL	208843033	FDA UDI	Class II	Active
Headless Screw System	401-20326	FDA UDI	Class II	Active
A.L.P.S. mvX™	770714102	EUDAMEDFDA UDI	Class II	Active
Orion Headed Screw	HTR-04-454905	FDA UDI	Class II	Active
Fps	M25-301036	FDA UDI	Class II	Active
Cannulated Screw System +	04.353.904	FDA UDI	Class II	Active
Snap-Off Screw System	410-30216	FDA UDI	Class II	Active
ACIS® ProTi 360™ HL	208843337	FDA UDI	Class II	Active
Tyber Medical	302-P2417410-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770200012	EUDAMEDFDA UDI	Class II	Active
Omnia Medical TLS	OM-TLS4540	FDA UDI	Class II	Unknown
Snap-Off Screw System	410-20412	FDA UDI	Class II	Active
Headless Screw System	401-15210	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76344034SH	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76357040LG	FDA UDI	Class II	Active
Orion Headed Screw System Instruments	HTR-04-609893	FDA UDI	Class I	Active
Tyber Medical	502-P2413010-S	FDA UDI	Class II	Active
Tyber Medical	302-P289410-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770607090	EUDAMEDFDA UDI	Class II	Active
Tyber Medical	Headless Ø6.5 x 54mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	302-P30828-S	FDA UDI	Class II	Active
Tyber Medical	25-26101108	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-301016-0	FDA UDI	Class II	Active
Headless Screw System	401-20310	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65250	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76325542LG	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