TransFasten - LSF (Lateral Sacroiliac Fusion System)

GUDID M73910110400

Sacroiliac Immobilization Device - 9mm (D) x 40mm (L)

CAPTIVA SPINE, INC.

Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated
Primary Device IDM73910110400
NIH Device Record Keyd59315e9-7d09-47cd-8454-5da365cf444a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransFasten - LSF (Lateral Sacroiliac Fusion System)
Version Model Number10-1-1040
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com
Phone561-277-9480
Emailinfo@captivaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM73910110400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


[M73910110400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-11
Device Publish Date2024-03-01

On-Brand Devices [TransFasten - LSF (Lateral Sacroiliac Fusion System)]

M73910110650Sacroiliac Immobilization Device - 9mm (D) x 65mm (L)
M73910110600Sacroiliac Immobilization Device - 9mm (D) x 60mm (L)
M73910110550Sacroiliac Immobilization Device - 9mm (D) x 55mm (L)
M73910110500Sacroiliac Immobilization Device - 9mm (D) x 50mm (L)
M73910110450Sacroiliac Immobilization Device - 9mm (D) x 45mm (L)
M73910110400Sacroiliac Immobilization Device - 9mm (D) x 40mm (L)
M73910110350Sacroiliac Immobilization Device - 9mm (D) x 35mm (L)
M73910110300Sacroiliac Immobilization Device - 9mm (D) x 30mm (L)
M73910110250Sacroiliac Immobilization Device - 9mm (D) x 25mm (L)

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