FDA.reportPublic FDA data

Osseointegration Prosthetic Limb

Primary DI
19356371001039
Brand
Osseointegration Prosthetic Limb
Company
OSSEOINTEGRATION INTERNATIONAL PTY LTD
Model
5 mm Hex Grub Screw - M10
Catalog number
OPL-LLCM10-C-GS
Device description
5 mm Hex Grub Screw - M10
Published
2022-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
IQODevice, Prosthesis Alignment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQODevice, Prosthesis AlignmentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
19356371001039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1935637100103919356371001039

GMDN Terms#

Term, Definition table
TermDefinition
External lower-limb prosthesis structural/alignment componentA 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.

Regulatory Flags#

DUNS number
743779676
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
19356371001091Osseointegration Prosthetic LimbO-RingOPL-LLC-OR2023-06-14
19356371001107Osseointegration Prosthetic LimbM10 ScrewOPL-LLCM10-DLS2023-06-14
19356371001114Osseointegration Prosthetic LimbM14 ScrewOPL-LLCM14-DLS2023-06-14
19356371001121Osseointegration Prosthetic Limb8 mm Hex Clamp ScrewOPL-LLC-C-S2023-06-14
19356371001008Osseointegration Prosthetic LimbM10 Grub Screw Tibial ConnectorOPL-LLCM10-TT2022-12-16
19356371001015Osseointegration Prosthetic LimbM10 Grub Screw Left ConnectorOPL-LLCM10-TF-L2022-12-16
19356371001022Osseointegration Prosthetic LimbM10 Grub Screw Right ConnectorOPL-LLCM10-TF-R2022-12-16
19356371001046Osseointegration Prosthetic Limb8 mm Hex Clamp ScrewOPL-LLC-C-S2022-12-16
19356371001053Osseointegration Prosthetic Limb0 Degree BushingOPL-LLC-B2022-12-16
19356371001060Osseointegration Prosthetic Limb8 Rotational Offset Taper SleeveOPL-LLC-TS2022-12-16
19356371001077Osseointegration Prosthetic LimbM10 ScrewOPL-LLCM10-DLS2022-12-16
19356371001084Osseointegration Prosthetic LimbM14 ScrewOPL-LLCM14-DLS2022-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186912Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00841747186929Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00195411036455Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036622Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036790Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036813Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411108602Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192298Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192304Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192311Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192328Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192342Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192359Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192366Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192373Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192380Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192397Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192403Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192410Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192427Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192434Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214440Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214457Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269150Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269167Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269174Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269181Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269198Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269204Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269211Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26