TRESTLE ANTERIOR CERVICAL PLATING SYSTEM

GUDID 00844856000247

ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 26

ALPHATEC SPINE, INC.

Orthopaedic fixation plate kit, non-bioabsorbable, sterile
Primary Device ID00844856000247
NIH Device Record Key6c7731f3-4f73-4100-b590-d104a39c5559
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRESTLE ANTERIOR CERVICAL PLATING SYSTEM
Version Model Number61002-026
Company DUNS602465783
Company NameALPHATEC SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

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

Device Dimensions

Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100844856000247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


[00844856000247]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-08-01

On-Brand Devices [TRESTLE ANTERIOR CERVICAL PLATING SYSTEM]

00844856099210ANTERIOR CERVICAL PLATE, 2 LEVEL, SIZE 35
008448560012064.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 20mm
008448560011904.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 19mm
008448560011834.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 18mm
008448560011764.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 17mm
008448560011694.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 16mm
008448560011524.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 15mm
008448560011454.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 14mm
008448560011384.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 13mm
008448560011214.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 12mm
008448560011144.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 11mm
008448560011074.5 SEMI CONSTRAINED SELF-TAPPING SCREW, 10mm
008448560010914.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 20mm
008448560010844.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 19mm
008448560010774.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 18mm
008448560010604.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 17mm
008448560010534.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 16mm
008448560010464.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 15mm
008448560010394.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 14mm
008448560010224.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 13mm
008448560010154.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 12mm
008448560010084.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 11mm
008448560009954.0 SEMI CONSTRAINED SELF-TAPPING SCREW, 10mm
008448560009884.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 20mm
008448560009714.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 19mm
008448560009644.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 18mm
008448560009574.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 17mm
008448560009404.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 16mm
008448560009334.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 15mm
008448560009264.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 14mm
008448560009194.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 13mm
008448560009024.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 12mm
008448560008964.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 11mm
008448560008894.0 SEMI CONSTRAINED SELF-DRILLING SCREW, 10mm
008448560008724.5 VARIABLE ANGLE SELF-TAPPING SCREW, 20mm
008448560008654.5 VARIABLE ANGLE SELF-TAPPING SCREW, 19mm
008448560008584.5 VARIABLE ANGLE SELF-TAPPING SCREW, 18mm
008448560008414.5 VARIABLE ANGLE SELF-TAPPING SCREW, 17mm
008448560008344.5 VARIABLE ANGLE SELF-TAPPING SCREW, 16mm
008448560008274.5 VARIABLE ANGLE SELF-TAPPING SCREW, 15mm
008448560008104.5 VARIABLE ANGLE SELF-TAPPING SCREW, 14mm
008448560008034.5 VARIABLE ANGLE SELF-TAPPING SCREW, 13mm
008448560007974.5 VARIABLE ANGLE SELF-TAPPING SCREW, 12mm
008448560007804.5 VARIABLE ANGLE SELF-TAPPING SCREW, 11mm
008448560007734.5 VARIABLE ANGLE SELF-TAPPING SCREW, 10mm
008448560007664.0 VARIABLE ANGLE SELF-TAPPING SCREW, 20mm
008448560007594.0 VARIABLE ANGLE SELF-TAPPING SCREW, 19mm
008448560007424.0 VARIABLE ANGLE SELF-TAPPING SCREW, 18mm
008448560007354.0 VARIABLE ANGLE SELF-TAPPING SCREW, 17mm
008448560007284.0 VARIABLE ANGLE SELF-TAPPING SCREW, 16mm

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