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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 3 of 208

Device	Model / Reference	Registries	Class	Status
Cannulated Screw System +	04.353.906	FDA UDI	Class II	Active
Tyber Medical	502-P32728-S	FDA UDI	Class II	Active
Fps	M25-251028	FDA UDI	Class II	Active
Tyber Medical	302-P3013010-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø6.5 x 95mm Full Thread Ti (Torx)	FDA UDI	Class II	Unknown
Tyber Medical	302-P2614810-S	FDA UDI	Class II	Active
ACIS® ProTi 360°™	108843111	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB50438	FDA UDI	Class II	Active
Snap-Off Screw System	410-30413	FDA UDI	Class II	Active
Sterile ACIF PEEK	810-160875	FDA UDI	Class II	Active
Tyber Medical	002-000070	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 39mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Tyber Medical	302-P268812-S	FDA UDI	Class II	Active
Focus TyPEEK	SV2609P	FDA UDI	Class II	Active
Tyber Medical	Headless Ø6.5 x 32mm Long Thread Ti (Torx)	FDA UDI	Class II	Active
Leos	7621-2724	FDA UDI	Class II	Active
Fps	M25-303011	FDA UDI	Class II	Active
Cannulated Screw System +	04.354.024	FDA UDI	Class II	Active
Fps	M25-401030	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76357056LG	FDA UDI	Class II	Active
Snap-Off Screw System	410-15213	FDA UDI	Class II	Active
Tyber Medical	Headless Ø4.5 x 35mm Full Thread Ti (Torx)	FDA UDI	Class II	Active
ToeGrip® Retrograde	TGRMM00	FDA UDI	Class II	Active
Fps	M25-401036	FDA UDI	Class II	Active
Tyber Medical	502-P2616410-S	FDA UDI	Class II	Active
Snap-Off Screw System	410-25323	FDA UDI	Class II	Active
Tyber Medical	302-P2610010-S	FDA UDI	Class II	Active
Tyber Medical	302-P227812-S	FDA UDI	Class II	Active
Tyber Medical	Headed Cannulated Screw Long Ø4.5mm x 44mm	FDA UDI	Class II	Active
Focus TyPEEK	SV2612L	FDA UDI	Class II	Active
Tyber Medical	502-P22848-S	FDA UDI	Class II	Active
Orion Headed Screw	HTR-04-254112	FDA UDI	Class II	Unknown
Tyber Medical	Headed Cannulated Screw Short Ø2.5mm x 29mm	FDA UDI	Class II	Active
Cannulated Compression Headless Screw	1ZB50375	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76308574	FDA UDI	Class I	Active
Fps	F25-007125	FDA UDI	Class I	Active
Tyber Medical	502-P307212-S	FDA UDI	Class II	Active
Ti-Fix OLIF Spacer	P-281015-0	FDA UDI	Class II	Active
TPLIF Interbody System	M2-T269523-S	FDA UDI	Class II	Active
A.L.P.S. mvX™	770271070	FDA UDI	Class II	Active
Tyber Medical	502-P2213810-S	FDA UDI	Class II	Active
LEOS Cannulated Screw System	76313516	FDA UDI	Class II	Active
Fps	F25-000051	FDA UDI	Class I	Active
CONCORDE® ProTi 360°™	188823509	FDA UDI	Class II	Active
A.L.P.S. mvX™	770150008	EUDAMEDFDA UDI	Class II	Active
Cannulated Screw System +	04.354.715	FDA UDI	Class II	Active
Tyber Medical	302-P321208-S	FDA UDI	Class II	Active
Tyber Medical	Headless Ø6.5 x 55mm Long Thread Ti (Torx)	FDA UDI	Class II	Unknown
Fps	M25-304026	FDA UDI	Class II	Active
Fps	M25-252018	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