EquiLOX Lumbar Expandable Cage - Graft Impactor

GUDID 00850065741352

Graft Impactor

CAPTIVA SPINE, INC.

Surgical tamp, reusable
Primary Device ID00850065741352
NIH Device Record Keyf8b09d94-9c00-42ca-9c19-822a445b8525
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquiLOX Lumbar Expandable Cage - Graft Impactor
Version Model NumberCSE06-R-0500-94
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850065741352 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


[00850065741352]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-02
Device Publish Date2024-11-22

Devices Manufactured by CAPTIVA SPINE, INC.

00850065741321 - EquiLOX Lumbar Expandable Cage2024-12-02 Expandable Lumbar Cage 24mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
00850065741338 - EquiLOX Lumbar Expandable Cage2024-12-02 Expandable Lumbar Cage 28mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
00850065741345 - EquiLOX Lumbar Expandable Cage2024-12-02 Expandable Lumbar Cage 32mm (L) x 10mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA)
00850065741352 - EquiLOX Lumbar Expandable Cage - Graft Impactor2024-12-02Graft Impactor
00850065741352 - EquiLOX Lumbar Expandable Cage - Graft Impactor2024-12-02 Graft Impactor
00850065741369 - EquiLOX Lumbar Expandable Cage - Bone Graft Funnel2024-12-02 Bone Graft Funnel
00850065741376 - EquiLOX Lumbar Expandable Cage - Holder shaft2024-12-02 Cage Holder - Retention Rod Center Shaft
00850065741000 - EquiLOX Lumbar Expandable Cage - Bone Impactor2024-07-24 Bone impactor
00850065741017 - EquiLOX Lumbar Expandable Cage - Funnel2024-07-24 Funnel

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