Distraction Paddle - 7mm

GUDID 00850065741628

Distraction Paddle - 7mm

CAPTIVA SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00850065741628
NIH Device Record Key6a184d18-a66c-4569-a819-78c49e5a424c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDistraction Paddle - 7mm
Version Model NumberCSE06-R-1800-39
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850065741628 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850065741628]

Moist Heat or Steam Sterilization


[00850065741628]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-27
Device Publish Date2025-08-19

Devices Manufactured by CAPTIVA SPINE, INC.

00850065741567 - Trial 7mm 2025-08-27 7mm Trial
00850065741574 - Trial 8mm2025-08-27 8mm Trial
00850065741581 - Trial 9mm2025-08-27 9mm Trial
00850065741598 - Trial 10mm2025-08-27 10mm Trial
00850065741604 - Trial 11mm2025-08-27 11mm Trial
00850065741611 - Trial 12mm2025-08-27 12mm Trial
00850065741628 - Distraction Paddle - 7mm2025-08-27Distraction Paddle - 7mm
00850065741628 - Distraction Paddle - 7mm2025-08-27 Distraction Paddle - 7mm
00850065741635 - Distraction Paddle - 8mm2025-08-27 Distraction Paddle - 8mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.