FDA.reportPublic FDA data

Able Medical Devices

Primary DI
00810071391453
Brand
Able Medical Devices
Company
J.M. Longyear Manufacturing, LLC
Model
05-06-2528
Catalog number
05-06-2528
Device description
Ball End Temporary Fixation Pin
Published
2024-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071391453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071391453008100713914538100713914530810071391453

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081307059
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810071391460Able Medical Devices01-08-303501-08-30352026-05-26
00810071390845Valkyrie Rib Thoracic Fixation System05-000-0805-000-082023-12-20
00810071390852Valkyrie Rib Thoracic Fixation System05-500-1205-500-122023-12-20
00810071390869Valkyrie Rib Thoracic Fixation System05-300-1605-300-162023-12-20
00810071390883Valkyrie Rib Thoracic Fixation System05-2507-105-2507-12023-12-20
00810071390890Valkyrie Rib Thoracic Fixation System05-2507-305-2507-32023-12-20
00810071390906Valkyrie Rib Thoracic Fixation System05-2507-805-2507-82023-12-20
00810071390944Valkyrie Rib Thoracic Fixation System05-2509-105-2509-12023-12-20
00810071390951Valkyrie Rib Thoracic Fixation System05-2509-305-2509-32023-12-20
00810071390968Valkyrie Rib Thoracic Fixation System05-2509-805-2509-82023-12-20
00810071391002Valkyrie Rib Thoracic Fixation System05-2511-105-2511-12023-12-20
00810071391019Valkyrie Rib Thoracic Fixation System05-2511-305-2511-32023-12-20
00810071391026Valkyrie Rib Thoracic Fixation System05-2511-805-2511-82023-12-20
00810071391064Valkyrie Rib Thoracic Fixation System05-2513-105-2513-12023-12-20
00810071391071Valkyrie Rib Thoracic Fixation System05-2513-305-2513-32023-12-20
00810071391088Valkyrie Rib Thoracic Fixation System05-2513-805-2513-82023-12-20
00810071391125Valkyrie Rib Thoracic Fixation System05-2515-105-2515-12023-12-20
00810071391132Valkyrie Rib Thoracic Fixation System05-2515-305-2515-32023-12-20
00810071391149Valkyrie Rib Thoracic Fixation System05-2515-805-2515-82023-12-20
00810071391156Valkyrie Rib Thoracic Fixation System05-2807-105-2807-12023-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
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00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
00840097536699Kinos Aeros InstrumentationRestor3d, Inc.LXH2026-07-20
08809945895304EXULTCorentec Co., LtdLXH2026-07-20
B504SRAR1930S0ArthrexProvisionLXH2026-07-20
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17