FDA.reportPublic FDA data

External lower-limb prosthesis structural/alignment component

Definition
A component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.
GUDID devices
226
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
19356371001008Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTDM10 Grub Screw Tibial Connector2022-12-16
19356371001015Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTDM10 Grub Screw Left Connector2022-12-16
19356371001022Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTDM10 Grub Screw Right Connector2022-12-16
19356371001039Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTD5 mm Hex Grub Screw - M102022-12-16
19356371001046Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTD8 mm Hex Clamp Screw2022-12-16
19356371001053Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTD0 Degree Bushing2022-12-16
19356371001060Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTD8 Rotational Offset Taper Sleeve2022-12-16
19356371001077Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTDM10 Screw2022-12-16
19356371001084Osseointegration Prosthetic LimbOSSEOINTEGRATION INTERNATIONAL PTY LTDM14 Screw2022-12-16
00628774388003Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00062026-03-02
00628774388010Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00122026-03-02
00628774388041Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00012026-03-02
00628774388058Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00022026-03-02
00628774388164Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00042026-03-02
00628774388171Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00052026-03-02
00628774388188Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00032026-03-02
00628774388195Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00112026-03-02
00628774388201Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00102026-03-02
00628774388218Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00092026-03-02
00628774388225Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00082026-03-02
00628774388232Kinn Automatic Volume Management SystemVessl Prosthetics IncKIT-00072026-03-02
00841747186912Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TA WT250 302025-05-28
00841747186929Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TA WT430 302025-05-28
05060624127304CS Carbon Spine Extension FrameCARE SURGICAL LIMITEDCSM27302025-03-28
04719883461698TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.F-TSF-FFH0126L2025-01-10
04719883463432TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-RA352025-01-10
04719883463449TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-RA382025-01-10
04719883463456TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-RA412025-01-10
04719883463463TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-SA412025-01-10
04719883464286TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-SA352025-01-10
04719883464859TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-SB242025-01-10
04719883464866TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-RB182025-01-10
04719883464873TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-RB212025-01-10
04719883464880TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.G-TCS-RB242025-01-10
04719883460165TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFML2023-10-31
04719883460523TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-KD-L2023-10-31
04719883460554TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFLL2023-10-31
04719883460608TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TKR-012023-10-31
04719883460622TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TLP-AAH2023-10-31
04719883460660TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-ECR2023-10-31
04719883460714TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-KDCS-L2023-10-31
04719883460745TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TTC-152023-10-31
04719883460912TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-ECL2023-10-31
04719883462343TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFLR2023-10-31
04719883462350TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFMR2023-10-31
04719883462367TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFSL2023-10-31
04719883462374TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFSR2023-10-31
04719883462381TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFXSL2023-10-31
04719883462398TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.H-TFC-DFXSR2023-10-31
04719883462589TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.B-TTG-142023-10-31
04719883462602TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TKC-CAP2023-10-31
04719883462657TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TLCA-40012023-10-31
04719883462664TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TUPS-MP12023-10-31
04719883462718TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-A2023-10-31
04719883462732TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-BX2023-10-31
04719883462749TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-PSDS2023-10-31
04719883462756TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-WC2023-10-31
04719883462763TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TSC-B2023-10-31
04719883462909TEHLINTEH LIN PROSTHETIC & ORTHOPAEDIC INC.D-TWP-A22023-10-31
00195411036455Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.4HTP 10 A2023-10-26
00195411036622Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TA T250 302023-10-26
00195411036790Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TA T430 302023-10-26
00195411036813Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TC T 302023-10-26
00195411108602Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TC T 252023-10-26
00195411192298Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TI TTK PAR2023-10-26
00195411192304Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TI TTK PHR2023-10-26
00195411192311Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TR S2023-10-26
00195411192328Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.TR T2023-10-26
00195411192342Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.2530K PA2023-10-26
00195411192359Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.2530K PAP2023-10-26
00195411192366Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.25K PAP2023-10-26
00195411192373Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.3PA AHR S2023-10-26
00195411192380Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.3PA AHR T2023-10-26
00195411192397Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.3PA R2023-10-26
00195411192403Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.3PA RR S2023-10-26
00195411192410Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.3PA RR T2023-10-26
00195411192427Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.4ESAH S2023-10-26
00195411192434Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.4ESAH T2023-10-26
00195411214440Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.4HFK 14P2023-10-26
00195411214457Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.4HFK 252023-10-26