EquiLOX Lumbar Expandable Cage - Torque Handle (2.5 Nm)

GUDID 00850065741260

Torque Handle (2.5 Nm)

CAPTIVA SPINE, INC.

Surgical instrument handle, torque-limiting
Primary Device ID00850065741260
NIH Device Record Key5f806504-4168-4ce5-9d0a-3ee799ecdb72
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquiLOX Lumbar Expandable Cage - Torque Handle (2.5 Nm)
Version Model NumberCSE06-R-0500-87
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
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
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
GS100850065741260 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


[00850065741260]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-24
Device Publish Date2024-07-16

Devices Manufactured by CAPTIVA SPINE, INC.

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00850065741413 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 24mm (L) x 12mm (W) x 10mm (H1) - 15mm (H2) x 9deg (LA) (sterile)
00850065741420 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 24mm (L) x 12mm (W) x 11mm (H1) - 16mm (H2) x 12deg (LA) (sterile)
00850065741437 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 24mm (L) x 12mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA) (sterile)
00850065741444 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 28mm (L) x 12mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA) (sterile)
00850065741451 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 28mm (L) x 12mm (W) x 8mm (H1) - 13mm (H2) x 3deg (LA) (sterile)

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