Primary Device ID | M739CP300900 |
NIH Device Record Key | 849b3849-bdd7-4949-b52f-9dd627bd3633 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | 4-Level Cervical Plates, 90 mm |
Version Model Number | CP30090 |
Company DUNS | 836975784 |
Company Name | CAPTIVA SPINE, INC. |
Device Count | 1 |
DM Exempt | false |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M739CP300900 [Primary] |
KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Steralize Prior To Use | true |
Device Is Sterile | false |
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
[M739CP300900]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-09-18 |
Device Publish Date | 2017-08-11 |
M739203000210 - 4-Hole Drill Guide | 2024-03-19 4-Hole LD Drill Guide |
M739985221229 - TransFasten | 2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Non-Threaded Trocar |
M739985221305 - TransFasten | 2024-03-19 LD (.125” Wire) Marking Pin, 305mm, Non-Threaded Trocar |
M739985222229 - TransFasten | 2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Conical Blunt |
M73910110250 - TransFasten - LSF (Lateral Sacroiliac Fusion System) | 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 25mm (L) |
M73910110300 - TransFasten - LSF (Lateral Sacroiliac Fusion System) | 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 30mm (L) |
M73910110350 - TransFasten - LSF (Lateral Sacroiliac Fusion System) | 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 35mm (L) |
M73910110400 - TransFasten - LSF (Lateral Sacroiliac Fusion System) | 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 40mm (L) |