2-Level Cervical Plates, 38mm

GUDID M739CP30038

2-Level Cervical Plates, 38mm

CAPTIVA SPINE, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device IDM739CP30038
NIH Device Record Keya2700550-c2d1-4fd9-a101-6a8d3ead4070
Commercial Distribution Discontinuation2017-08-11
Commercial Distribution StatusNot in Commercial Distribution
Brand Name2-Level Cervical Plates, 38mm
Version Model NumberCP30038
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM739CP30038 [Primary]

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


[M739CP30038]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-09-18
Device Publish Date2015-08-28

Devices Manufactured by CAPTIVA SPINE, INC.

M739203000210 - 4-Hole Drill Guide2024-03-19 4-Hole LD Drill Guide
M739985221229 - TransFasten2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Non-Threaded Trocar
M739985221305 - TransFasten2024-03-19 LD (.125” Wire) Marking Pin, 305mm, Non-Threaded Trocar
M739985222229 - TransFasten2024-03-19 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)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.