FDA.reportPublic FDA data

TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mm

Primary DI
M73910290130
Brand
TransFasten - LSF, Sharp Guide Pin Ø3.2mm x 229mm
Company
CAPTIVA SPINE, INC.
Model
10-2-9013
Device description
Sharp Guide Pin Ø3.2mm x 229mm
Published
2024-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXYBrace, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXYBrace, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M73910290130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
561-277-9480info@captivaspine.com

Regulatory Flags#

DUNS number
836975784
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
M739131064012Variable Screw, Self-Tapping, 4.0mm x 12mm13106-40122015-10-30
M739131064014Variable Screw, Self-Tapping, 4.0mm x 14mm13106-40142015-10-30
M739131064016Variable Screw, Self-Tapping, 4.0mm x 16mm13106-40162015-10-30
M739131064018Variable Screw, Self-Tapping, 4.0mm x 18mm13106-40182015-10-30
M739131164012Fixed Screw, Self-Tapping, 4.0mm x 12mm13116-40122015-10-30
M739131164014Fixed Screw, Self-Tapping, 4.0mm x 14mm13116-40142015-10-30
M739131164016Fixed Screw, Self-Tapping, 4.0mm x 16mm13116-40162015-10-30
M739131164018Fixed Screw, Self-Tapping, 4.0mm x 18mm13116-40182015-10-30
M73924712832Cross Connector, XSmall2471-28322015-10-30
M73924713139Cross Connector, Small2471-31392015-10-30
M73924713752Cross Connector, Medium2471-37522015-10-30
M73924714963Cross Connector, Medium-Large2471-49632015-10-30
M73924714975Cross Connector, Large2471-49752015-10-30
M739CP300201-Level Cervical Plates, 20 mmCP300202015-10-30
M739CP3002001-Level Cervical Plates, 20 mmCP300202017-08-11
M739CP300221-Level Cervical Plates, 22 mmCP300222015-08-28
M739CP3002201-Level Cervical Plates, 22 mmCP300222017-08-11
M739CP300241-Level Cervical Plates, 24 mmCP300242015-08-28
M739CP3002401-Level Cervical Plates, 24 mmCP300242017-08-11
M739CP300261-Level Cervical Plates, 26 mmCP300262015-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862605764EPICExactech, Inc.HXY2026-04-28
05055662970593ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-08-14
05055662971293Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971309Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971316Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
05055662971323Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2025-06-23
00889024682399PSN TM TIB DRILL GDEZimmer, Inc.HXY2025-01-13
00810027271594Citrelock ACL Tibial Drill Guide, Flat HookAcuitive Technologies, Inc.HXY2024-12-03
00191083044569Meniscus Allograft Transplantation (MAT)Rti Surgical, Inc.HXY2024-10-14
04049197096812RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-16
04049197096744RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-07-15
04026575534678LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04026575534739LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGHXY2024-07-11
04049197187848RZ Medizintechnik GmbHRZ-Medizintechnik GmbHHXY2024-06-28
00840183516031BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
00840183516048BR Surgical, LLCBR Surgical, LLCHXY2024-06-03
M73910290060TransFasten-LSF, Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290140TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 229mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290150TransFasten - LSF, Blunt Guide Pin Ø3.2mm x 457mmCAPTIVA SPINE, INC.HXY2024-04-25
M73910290170TransFasten - LSF, Open-Ended Offset GuideCAPTIVA SPINE, INC.HXY2024-04-25
M73910290180TransFasten - LSF, Parallel GuideCAPTIVA SPINE, INC.HXY2024-04-25
05055662969825COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969832COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969849COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969856COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969863COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
05055662969870COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXY2024-04-01
M7392030002104-Hole Drill GuideCAPTIVA SPINE, INC.HXY2024-03-11
08033860019105BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23
08033860019112BIOPSYBELLBIOPSYBELL SRLHXY2024-02-23