TRESTLE ANTERIOR CERVICAL PLATING SYSTEM

GUDID 00844856099210

ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile

Primary Device ID	00844856099210
NIH Device Record Key	b3240c22-3fab-4f3c-b48f-4985f11b5b53
Commercial Distribution Status	In Commercial Distribution
Brand Name	TRESTLE ANTERIOR CERVICAL PLATING SYSTEM
Version Model Number	61002-035
Company DUNS	602465783
Company Name	ALPHATEC SPINE, INC.
Device Count	1
DM Exempt	true
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	true
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

Device Dimensions

Length	35 Millimeter
Length	35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844856099210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K102820

FDA Product Code

KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00844856099210]

Moist Heat or Steam Sterilization

[00844856099210]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-08-01

On-Brand Devices [TRESTLE ANTERIOR CERVICAL PLATING SYSTEM]

00844856099210	ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35
00844856001206	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 20mm
00844856001190	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 19mm
00844856001183	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 18mm
00844856001176	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 17mm
00844856001169	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 16mm
00844856001152	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 15mm
00844856001145	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 14mm
00844856001138	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 13mm
00844856001121	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 12mm
00844856001114	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 11mm
00844856001107	4.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 10mm
00844856001091	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 20mm
00844856001084	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 19mm
00844856001077	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 18mm
00844856001060	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 17mm
00844856001053	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 16mm
00844856001046	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 15mm
00844856001039	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 14mm
00844856001022	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 13mm
00844856001015	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 12mm
00844856001008	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 11mm
00844856000995	4.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 10mm
00844856000988	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 20mm
00844856000971	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 19mm
00844856000964	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 18mm
00844856000957	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 17mm
00844856000940	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 16mm
00844856000933	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 15mm
00844856000926	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 14mm
00844856000919	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 13mm
00844856000902	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 12mm
00844856000896	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 11mm
00844856000889	4.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 10mm
00844856000872	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 20mm
00844856000865	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 19mm
00844856000858	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 18mm
00844856000841	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 17mm
00844856000834	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 16mm
00844856000827	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 15mm
00844856000810	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 14mm
00844856000803	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 13mm
00844856000797	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 12mm
00844856000780	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 11mm
00844856000773	4.5 VARIABLE ANGLE SELF-TAPPING SCREW, 10mm
00844856000766	4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 20mm
00844856000759	4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 19mm
00844856000742	4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 18mm
00844856000735	4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 17mm
00844856000728	4.0 VARIABLE ANGLE SELF-TAPPING SCREW, 16mm