Patient-Fitted TMJ Reconstructive Prosthesis Syste

GUDID B0046123120

Bone Screw 2.3mm x 12mm

TMJ SOLUTIONS INC

Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis Total temporomandibular joint prosthesis
Primary Device IDB0046123120
NIH Device Record Key267bf43b-b06f-4ad6-ad99-fff9d95265f0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient-Fitted TMJ Reconstructive Prosthesis Syste
Version Model Number61-2312
Company DUNS035877922
Company NameTMJ SOLUTIONS 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emailgreg@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena@tmjconcepts.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com
Phone805-650-3391
Emaillorena.lundeen@stryker.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0046123120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZDJoint, Temporomandibular, Implant

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


[B0046123120]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-27

On-Brand Devices [Patient-Fitted TMJ Reconstructive Prosthesis Syste]

B004TYYNNNNRM0Right Mandibular Component
B004TYYNNNNRF0Right Fossa Component
B004TYYNNNNM0Anatomical Bone Model
B004TYYNNNNLM0Left Mandibular Component
B004TYYNNNNLF0Left Fossa Component
B0046523161Bone Screw 2.3mm x 16mm, 5 Pack
B0046523141Bone Screw 2.3mm x 14mm, 5 Pack
B0046523121Bone Screw 2.3mm x 12mm, 5 Pack
B0046523101Bone Screw 2.3mm x 10mm, 5 Pack
B0046523081Bone Screw 2.3mm x 8mm, 5 Pack
B0046523061Bone Screw 2.3mm x 6mm, 5 Pack
B0046520161Bone Screw 2.0mm x 16mm, 5 Pack
B0046520141Bone Screw 2.0mm x 14mm, 5 Pack
B0046520121Bone Screw 2.0mm x 12mm, 5 Pack
B0046520101Bone Screw 2.0mm x 10mm, 5 Pack
B0046520081Bone Screw 2.0mm x 8mm, 5 Pack
B0046520061Bone Screw 2.0mm x 6mm, 5 Pack
B0046520051Bone Screw 2.0mm x 5mm, 5 Pack
B0046123160Bone Screw 2.3mm x 16mm
B0046123140Bone Screw 2.3mm x 14mm
B0046123120Bone Screw 2.3mm x 12mm
B0046123100Bone Screw 2.3mm x 10mm
B0046123080Bone Screw 2.3mm x 8mm
B0046123060Bone Screw 2.3mm x 6mm
B0046120160Bone Screw 2.0mm x 16mm
B0046120140Bone Screw 2.0mm x 14mm
B0046120120Bone Screw 2.0mm x 12mm
B0046120100Bone Screw 2.0mm x 10mm
B0046120080Bone Screw 2.0mm x 8mm
B0046120060Bone Screw 2.0mm x 6mm
B0046120050Bone Screw 2.0mm x 5mm
B0046005200Sterilization Case Instrument Base
B0046005100Sterilization Case Screw Base
B0046005000Sterilization Case Lid
B0046004230Pilot Drill 2.3mm
B0046004200Pilot Drill 2.0mm
B0046003000Drill Guide
B0046002000Fossa Seating Tool
B0046001300Mandibular Forceps
B0046001200Implant Stabilizer
B0046001100Driver Blade
B0046001000Quick-Connect Instrument Handle
B0046000200TMJ Fixation Instrument Set (Loaner)
B0046000100TMJ Driver Handle and Blade (Loaner)

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