FDA.reportPublic FDA data

TransFasten

Primary DI
M7399851422030
Brand
TransFasten
Company
CAPTIVA SPINE, INC.
Model
98514-2203
Device description
Marking Pin, 203mm, Conical Blunt, SS
Published
2022-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
KILPositioner, Socket
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
KILPositioner, SocketOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7399851422030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intraoperative bone pin/screw, sterileA small sterile rod intended to be inserted into bone to temporarily anchor a surgical instrument (e.g., retractor, implant aligner) to bone during an orthopaedic surgical procedure; it is not left in situ after the procedure. It may be wholly- or partially-threaded for screwing into bone, and may have other physical features to enable fixation of surgical instruments. It is made of metallic (e.g., stainless steel) or polymer (radiolucent) material and is available in various shapes and sizes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length203Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00190776411091MillenniumAvalign Technologies, Inc.FZX2026-08-07
00841523183081Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523183746Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185030Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185047Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185054Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185061Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185078Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185092Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185108Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185139Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185146Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185153Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185160Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185177Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
00841523185382Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-08-07
06438408012815Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012822Inion CompressOn™ / Inion FreedomScrew™ InstrumentInion OyFZX2026-08-07
06438408012839Inion CompressOn™ InstrumentInion OyFZX2026-08-07
B382SD484620Surgical DirectSurgical Direct, Inc.LXH2026-08-07
M7409200004MIS TLIF SystemSPINEOLOGY INC.LXH2026-08-07
00199150083473Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-08-03
B382SD480033220Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD480090Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD4834330Surgical DirectSurgical Direct, Inc.LXH2026-08-03
B382SD493760Surgical DirectSurgical Direct, Inc.LXH2026-08-03
00190776407391MillenniumAvalign Technologies, Inc.LXH2026-07-31
00840606191579Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191630Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31
00840606191647Overwatch PCFSPINAL ELEMENTS, INC.LXH2026-07-31