FDA.reportPublic FDA data

PRO-SPEC

Primary DI
00810112599732
Brand
PRO-SPEC
Company
CROSSROADS EXTREMITY SYSTEMS
Model
TRIAL INSERTER FOR PRO-SPEC SYSTEM
Catalog number
03.845.999
Device description
TRIAL INSERTER FOR PRO-SPEC SYSTEM
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00810112599732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112599732008101125997328101125997320810112599732

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058864308
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592320TriLeap Lower Extremity Anatomic Plating System26MM Cannulated Cone Reamer03.900.3922024-02-23
00815432024322DynaForce MotoBAND Max7100-4H157100-4H152022-12-09
00815432024339DynaForce MotoBAND Max7100-4H187100-4H182022-12-09
00815432024353DynaForce MotoBAND Max7100-5H187100-5H182022-12-09
00815432024360DynaForce MotoBAND Max7100-99PN7100-99PN2022-12-09
00815432024377DynaForce MotoBAND Max7100-RD157100-RD152022-12-09
00815432024391DynaForce MotoBAND Max7100-RP157100-RP152022-12-09
00815432024407DynaForce MotoBAND Max7100-RP187100-RP182022-12-09
00815432024421DynaForce MotoBAND Max7100-TJ187100-TJ182022-12-09
00815432024438DynaForce MotoBAND Max7100-ZA157100-ZA152022-12-09
00815432027989MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-018R2020-11-12
00815432027996MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-018R2020-11-12
00815432028009MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-020R2020-11-12
00815432028016MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-020R2020-11-12
00815432028023MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-018L2020-11-12
00815432028030MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-018L2020-11-12
00815432028047MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7500-020L2020-11-12
00815432028054MotoBANDDynaForce MTP Standard Plate with Slot, 5deg valgu7505-020L2020-11-12
00815432028726MotoBANDImplant, 3.5mm x 28mm Anti-Drift Bolt15LP-35282020-05-27
00815432028795MotoBANDImplant, 3.5mm x 30mm Anti-Drift Bolt15LP-35302020-05-27

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00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
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00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
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00810055525362Onyx 6.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
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00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
00810055525393Onyx Straight ProbeSi-Bone Inc.LXH2026-09-29
00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29