Palm Handle

GUDID M739983227007

CAPTIVA SPINE, INC.

Bone awl, reusable
Primary Device IDM739983227007
NIH Device Record Key35ab4eab-dd18-422f-98a7-8583f6df4c4c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePalm Handle
Version Model Number98322-7007
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
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
HIBCCM739983227007 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


[M739983227007]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-12
Device Publish Date2025-03-04

Devices Manufactured by CAPTIVA SPINE, INC.

00850065741383 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 24mm (L) x 12mm (W) x 7mm (H1) - 11mm (H2) x 3deg (LA) (sterile)
00850065741390 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 24mm (L) x 12mm (W) x 8mm (H1) - 13mm (H2) x 3deg (LA) (sterile)
00850065741406 - EquiLOX Lumbar Expandable Cage2025-03-13 Expandable Lumbar Cage 24mm (L) x 12mm (W) x 9mm (H1) - 14mm (H2) x 6deg (LA) (sterile)
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)

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