FDA.report

Tendon spacer

Definition
An implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.
GUDID devices
13
Last updated
2025-12-25 15:58:11

Related Product Codes

CodeDeviceSpecialtyClassDevices
FTMMesh, SurgicalGeneral, Plastic Surgery26
QPQShoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-FixedOrthopedic23
JXICuff, NerveNeurology22
OWWMesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery22
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00860011716730B3 GEL SystemTybr Health, Inc.B3TNP040612025-12-17
07610221014200Geistlich Nexo-Gide®Geistlich Pharma AG5006622021-09-01
07610221014217Geistlich Nexo-Gide®Geistlich Pharma AG5006632021-09-01
07610221014224Geistlich Nexo-Gide®Geistlich Pharma AG5006642021-09-01
17290013396041InSpace™ORTHO-SPACE LTD01302021-08-01
17290013396058InSpace™ORTHO-SPACE LTD01312021-08-01
17290013396065InSpace™ORTHO-SPACE LTD01322021-08-01
B454VTP12010VersaWrapALAFAIR BIOSCIENCES, INCVTP-12012020-11-01
B454VTP22011VersaWrap Tendon ProtectorALAFAIR BIOSCIENCES, INCVTP22012020-10-23
B454VTP12011VersaWrap Tendon ProtectorALAFAIR BIOSCIENCES, INCVTP12012020-10-14
M269TG2211Tenoglide Tendon Protector SheetIntegra Lifesciences CorporationTG2212015-09-23
M269TG4511Tenoglide Tendon Protector SheetIntegra Lifesciences CorporationTG4512015-09-23
B454VTP22010VersaWrap Tendon ProtectorALAFAIR BIOSCIENCES, INCVTP22012016-12-15