Primary Device ID | M73910110400 |
NIH Device Record Key | d59315e9-7d09-47cd-8454-5da365cf444a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TransFasten - LSF (Lateral Sacroiliac Fusion System) |
Version Model Number | 10-1-1040 |
Company DUNS | 836975784 |
Company Name | CAPTIVA SPINE, INC. |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com | |
Phone | 561-277-9480 |
info@captivaspine.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M73910110400 [Primary] |
OUR | Sacroiliac Joint Fixation |
Steralize Prior To Use | true |
Device Is Sterile | false |
[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
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-03-11 |
Device Publish Date | 2024-03-01 |
M73910110650 | Sacroiliac Immobilization Device - 9mm (D) x 65mm (L) |
M73910110600 | Sacroiliac Immobilization Device - 9mm (D) x 60mm (L) |
M73910110550 | Sacroiliac Immobilization Device - 9mm (D) x 55mm (L) |
M73910110500 | Sacroiliac Immobilization Device - 9mm (D) x 50mm (L) |
M73910110450 | Sacroiliac Immobilization Device - 9mm (D) x 45mm (L) |
M73910110400 | Sacroiliac Immobilization Device - 9mm (D) x 40mm (L) |
M73910110350 | Sacroiliac Immobilization Device - 9mm (D) x 35mm (L) |
M73910110300 | Sacroiliac Immobilization Device - 9mm (D) x 30mm (L) |
M73910110250 | Sacroiliac Immobilization Device - 9mm (D) x 25mm (L) |