ATEC Lateral Navigation Instruments

GUDID 00190376476216

LIF NAV TRIAL 8 x 18 x 65 mm 10°

ALPHATEC SPINE, INC.

Surgical implant/trial-implant/sizer holder, reusable

Primary Device ID	00190376476216
NIH Device Record Key	267b1fce-157c-45cd-ab61-d5983b4c85d7
Commercial Distribution Status	In Commercial Distribution
Brand Name	ATEC Lateral Navigation Instruments
Version Model Number	266-10-08186510-N
Company DUNS	602465783
Company Name	ALPHATEC SPINE, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com
Phone	+1(760)431-9286
Email	Regulatory@alphatecspine.com

Device Dimensions

Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter
Length	65 Millimeter
Height	8 Millimeter
Angle	10 degree
Width	18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376476216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223765

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

[00190376476216]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-04
Device Publish Date	2023-08-26

On-Brand Devices [ATEC Lateral Navigation Instruments]

00190376523439	Alpha LIF Navigated Disc Prep
00190376522906	LIF NAV OSTEOTOME 14mm
00190376509792	LIF NAV, SHAVER 14mm
00190376509785	LIF NAV, SHAVER 12mm
00190376509778	LIF NAV, SHAVER 10mm
00190376509761	LIF NAV, SHAVER 8mm
00190376509754	LIF NAV, SHAVER 6mm
00190376494692	LIF NAV PRIMARY DILATOR
00190376477107	LIF NAV TRIAL 6 x 18 x 65 mm 10°
00190376476353	LIF NAV ENDPLATE SCRAPER 8mm
00190376476339	LIF NAV ENDPLATE SCRAPER SS 10mm
00190376476322	LIF NAV ENDPLATE SCRAPER SS 8mm
00190376476292	LIF NAV COBB 18mm
00190376476285	LIF NAV COBB 10mm
00190376476254	LIF NAV TRIAL 12 x 18 x 65 mm 10°
00190376476247	LIF NAV TRIAL 12 x 18 x 65 mm 0°
00190376476230	LIF NAV TRIAL 10 x 18 x 65 mm 10°
00190376476223	LIF NAV TRIAL 10 x 18 x 65 mm 0°
00190376476216	LIF NAV TRIAL 8 x 18 x 65 mm 10°
00190376476209	LIF NAV TRIAL 8 x 18 x 65 mm 0°
00190376476193	LIF NAV TRIAL 6 x 18 x 65 mm 0°
00190376476186	LIF NAV OSTEOTOME 12mm
00190376476179	LIF NAV OSTEOTOME 10mm
00190376476162	LIF NAV OSTEOTOME 8mm
00190376476155	LIF NAV PRIMARY DILATOR CANNULATED
00190376476070	LIF NAV ENDPLATE SCRAPER 10mm

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