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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 4 of 208

Device	Model / Reference	Registries	Class	Status
Tyber Medical	Headed Cannulated Screw Short Ø3.0mm x 14mm	FDA UDI	Class II	Unknown
Tyber Medical	Headed Cannulated Screw Short Ø3.0mm x 31mm	FDA UDI	Class II	Active
Headless Screw System Instruments	001-00004	FDA UDI	Class I	Active
Tyber Medical	Headless Ø4.5 x 36mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	Headless Ø4.5 x 56mm Short Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	302-P24708-S	FDA UDI	Class II	Active
Wedge System Instruments	GC-00014	FDA UDI	Class I	Active
Cannulated Screw System +	04.354.665TS	FDA UDI	Class II	Active
Riptide	6ZBC00000	FDA UDI	Class I	Active
Leos	7620-3516	FDA UDI	Class II	Active
Tyber Medical	502-T267501-S	FDA UDI	Class II	Active
Headed Screw System	9ZB20228	FDA UDI	Class II	Active
Tyber Medical	502-P2414012-S	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB65334	FDA UDI	Class II	Active
Fps	M25-303028	FDA UDI	Class II	Active
Tyber Medical	302-P2413412-S	FDA UDI	Class II	Active
Riptide	6ZBZC2508	FDA UDI	Class II	Active
Tyber Medical	502-P241188-S	FDA UDI	Class II	Active
Snap-Off Screw System	410-15416	FDA UDI	Class II	Active
Orion Headed Screw System Instruments	HTR-04-009524	FDA UDI	Class I	Active
Headed Screw System	409-45338	FDA UDI	Class II	Active
Tyber Medical	002-C14975	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-301013-0	FDA UDI	Class II	Active
Tyber Medical	502-P281788-S	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843406	FDA UDI	Class II	Active
Fps	M25-201017	FDA UDI	Class II	Active
Tyber Medical	302-P3012210-S	FDA UDI	Class II	Active
Fps	M25-401060	FDA UDI	Class II	Active
Tyber Medical	502-P241788-S	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843712	FDA UDI	Class II	Active
TyFix Hammertoe System	413-S30115-S	FDA UDI	Class II	Active
Leos	7620-3520	FDA UDI	Class II	Active
Foot Osteotomy Wedge System	03.844.153	FDA UDI	Class I	Active
Tyber Medical	Headless Ø6.5 x 35mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	PLIF 26mm x 10mm x 11mm x 0 Degree	FDA UDI	Class II	Active
Riptide	6ZBZE2112	FDA UDI	Class II	Active
A.L.P.S. mvX™	770400024	FDA UDI	Class II	Active
Tyber Medical	502-P261708-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø2.0 x 17mm Short Thread Ti (Torx)	FDA UDI	Class II	Unknown
A.L.P.S. mvX™	770131007	FDA UDI	Class II	Active
Riptide	6ZBZE2411	FDA UDI	Class II	Active
Leos	7621-4034	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76312028	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø6.5mm x 45mm	FDA UDI	Class II	Unknown
Tyber Medical	302-P3017212-S	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	002-P307010	FDA UDI	Class II	Active
TiLink-C	30-14120510	FDA UDI	Class II	Active
Tyber Medical	SV2712P	FDA UDI	Class II	Active
Tyber Medical	502-P261248-S	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø6.5mm x 60mm	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