SmartLOX Cervical Plate System

GUDID M7391334000160

16mm Drill Bit Spade Tip

CAPTIVA SPINE, INC.

Fluted surgical drill bit, reusable
Primary Device IDM7391334000160
NIH Device Record Key69c8a741-3224-4353-9154-b620a47f6484
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmartLOX Cervical Plate System
Version Model Number13340-0016
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 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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7391334000160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

[M7391334000160]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-09
Device Publish Date2021-03-01

On-Brand Devices [SmartLOX Cervical Plate System]

M739CP502100Plate Bender
M739CP502000Caliper 100mm
M739CP501900Pin Inserter
M739CP501800Cervical Plate Holder
M739CP501400Drill Handle With A/O Connect
M739CP501200Screwdriver With Handle
M739CP501000Bone Awl (retracting)
M739CP40018018mm Drill Bit
M739CP40017017mm Drill Bit
M739CP40016016mm Drill Bit
M739CP40015015mm Drill Bit
M739CP40014014mm Drill Bit
M739CP40013013mm Drill Bit
M739CP40012012mm Drill Bit
M739CP40011011mm Drill Bit
M739CP400010Temporary Fixation Pin
M7393030010000Locking Screwdriver
M7391349901040RLC Bone Awl Sleeve
M739133400018018mm Drill Bit Spade Tip
M739133400017017mm Drill Bit Spade Tip
M739133400016016mm Drill Bit Spade Tip
M739133400015015mm Drill Bit Spade Tip
M739133400014014mm Drill Bit Spade Tip
M739133400013013mm Drill Bit Spade Tip
M739133400012012mm Drill Bit Spade Tip
M739133400011011mm Drill Bit Spade Tip
M7391334010180MULTI-USE DRILL BIT 18mm-SPADE TIP
M7391334010170MULTI-USE DRILL BIT 17mm-SPADE TIP
M7391334010160MULTI-USE DRILL BIT 16mm-SPADE TIP
M7391334010150MULTI-USE DRILL BIT 15mm-SPADE TIP
M7391334010140MULTI-USE DRILL BIT 14mm-SPADE TIP
M7391334010130MULTI-USE DRILL BIT 13mm-SPADE TIP
M7391334010120MULTI-USE DRILL BIT 12mm-SPADE TIP
M7391334010110MULTI-USE DRILL BIT 11mm-SPADE TIP
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