EquiLOX Lumbar Expandable Cage

GUDID 00850065741208

Expandable Lumbar Cage 32mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 9deg (LA)

CAPTIVA SPINE, INC.

Spinal fusion sphere
Primary Device ID00850065741208
NIH Device Record Key51c79436-5c42-469c-a5bf-bce25ad2bc7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquiLOX Lumbar Expandable Cage
Version Model NumberCSF0301-B0032AB59S
Company DUNS836975784
Company NameCAPTIVA SPINE, INC.
Device Count1
DM Exempttrue
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

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
GS100850065741208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-22
Device Publish Date2024-07-12

On-Brand Devices [EquiLOX Lumbar Expandable Cage]

00850065741222Expandable Lumbar Cage 32mm (L) x 10mm (W) x 13mm (H1) - 18mm (H2) x 15deg (LA)
00850065741215Expandable Lumbar Cage 32mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 12deg (LA)
00850065741208Expandable Lumbar Cage 32mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 9deg (LA)
00850065741192Expandable Lumbar Cage 32mm (L) x 10mm (W) x 10mm (H1) - 15mm (H2) x 6deg (LA)
00850065741185Expandable Lumbar Cage 32mm (L) x 10mm (W) x 9mm (H1) - 13mm (H2) x 3deg (LA)
00850065741178Expandable Lumbar Cage 28mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA)
00850065741161Expandable Lumbar Cage 28mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 12deg (LA)
00850065741154Expandable Lumbar Cage 28mm (L) x 10mm (W) x 10mm (H1) - 15mm (H2) x 9deg (LA)
00850065741147Expandable Lumbar Cage 28mm (L) x 10mm (W) x 9mm (H1) - 14mm (H2) x 6deg (LA)
00850065741130Expandable Lumbar Cage 28mm (L) x 10mm (W) x 8mm (H1) - 13mm (H2) x 3deg (LA)
00850065741123Expandable Lumbar Cage 24mm (L) x 10mm (W) x 12mm (H1) - 17mm (H2) x 15deg (LA)
00850065741116Expandable Lumbar Cage 24mm (L) x 10mm (W) x 11mm (H1) - 16mm (H2) x 12deg (LA)
00850065741109Expandable Lumbar Cage 24mm (L) x 10mm (W) x 10mm (H1) - 15mm (H2) x 9deg (LA)
00850065741093Expandable Lumbar Cage 24mm (L) x 10mm (W) x 9mm (H1) - 14mm (H2) x 6deg (LA)
00850065741086Expandable Lumbar Cage 24mm (L) x 10mm (W) x 8mm (H1) - 13mm (H2) x 3deg (LA)

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