ATEC Posterior Navigation Disc Prep Instruments

GUDID 00190376528731

POST NAV PS Trial 8 x 9 x 22mm, 10°

ALPHATEC SPINE, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

Primary Device ID	00190376528731
NIH Device Record Key	05e38ec4-8d38-4322-95da-39b73ef0455f
Commercial Distribution Status	In Commercial Distribution
Brand Name	ATEC Posterior Navigation Disc Prep Instruments
Version Model Number	244-05-08092210-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

Device Dimensions

Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter
Length	22 Millimeter
Width	9 Millimeter
Angle	10 degree
Height	8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190376528731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K232345

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

[00190376528731]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-29
Device Publish Date	2024-04-20

On-Brand Devices [ATEC Posterior Navigation Disc Prep Instruments]

00190376588131	Posterior Navigated Disc Prep Supplementary Set
00190376588124	Posterior Navigated Disc Prep Instrument Set
00190376542560	POST NAV RING CURETTE, 10mm
00190376531717	NAV OFFSET HANDLE
00190376530260	NAV OFFSET HANDLE ADAPTER
00190376530055	POST NAV RING CURETTE, 8mm
00190376530048	POST NAV RING CURETTE, 6mm
00190376529295	POST NAV ROTATING DISTRACTOR, 14mm
00190376529288	POST NAV ROTATING DISTRACTOR, 13mm
00190376529271	POST NAV ROTATING DISTRACTOR, 12mm
00190376529264	POST NAV ROTATING DISTRACTOR, 11mm
00190376529257	POST NAV ROTATING DISTRACTOR, 10mm
00190376529240	POST NAV ROTATING DISTRACTOR, 9mm
00190376529233	POST NAV ROTATING DISTRACTOR, 8mm
00190376529226	POST NAV ROTATING DISTRACTOR, 7mm
00190376529219	POST NAV ROTATING DISTRACTOR, 6mm
00190376529189	POST NAV OSTEOTOME, 12mm
00190376529158	POST NAV OSTEOTOME, 6mm
00190376529141	POST NAV ROTATING SHAVER, 14MM
00190376529134	POST NAV ROTATING SHAVER, 13MM
00190376529127	POST NAV ROTATING SHAVER, 12MM
00190376529110	POST NAV ROTATING SHAVER, 11MM
00190376529103	POST NAV ROTATING SHAVER, 10MM
00190376529097	POST NAV ROTATING SHAVER, 9MM
00190376529080	POST NAV ROTATING SHAVER, 8MM
00190376529073	POST NAV ROTATING SHAVER, 7MM
00190376529066	POST NAV ROTATING SHAVER, 6MM
00190376529042	POST NAV RIGHT-BEND CUP CURETTE, SIZE 2
00190376529035	POST NAV LEFT-BEND CUP CURETTE, SIZE 2
00190376529028	POST NAV PUSH CUP CURETTE, SIZE 2
00190376529004	POST NAV STRAIGHT CUP CURETTE, SIZE 2
00190376528984	POST NAV ENDPLATE SCRAPER, 10mm
00190376528977	POST NAV ENDPLATE SCRAPER, 8mm
00190376528960	POST NAV ENDPLATE SCRAPER, 6mm
00190376528861	POST NAV PS Trial 11 x 9 x 22mm, 15°
00190376528854	POST NAV PS Trial 11 x 9 x 22mm, 10°
00190376528847	POST NAV PS Trial 11 x 9 x 22mm, 5°
00190376528830	POST NAV PS Trial 11 x 9 x 22mm, 0°
00190376528823	POST NAV PS Trial 10 x 9 x 22mm, 15°
00190376528816	POST NAV PS Trial 10 x 9 x 22mm, 10°
00190376528809	POST NAV PS Trial 10 x 9 x 22mm, 5°
00190376528793	POST NAV PS Trial 10 x 9 x 22mm, 0°
00190376528786	POST NAV PS Trial 9 x 9 x 22mm, 15°
00190376528779	POST NAV PS Trial 9 x 9 x 22mm, 10°
00190376528762	POST NAV PS Trial 9 x 9 x 22mm, 5°
00190376528755	POST NAV PS Trial 9 x 9 x 22mm, 0°
00190376528748	POST NAV PS Trial 8 x 9 x 22mm, 15°
00190376528731	POST NAV PS Trial 8 x 9 x 22mm, 10°
00190376528724	POST NAV PS Trial 8 x 9 x 22mm, 5°
00190376528717	POST NAV PS Trial 8 x 9 x 22mm, 0°

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