Patient-Fitted TMJ Reconstructive Prosthesis System

GUDID 07613327626810

2.3 x 14 mm Self-Tapping Bone Screw

TMJ Solutions, Inc.

Total temporomandibular joint prosthesis
Primary Device ID07613327626810
NIH Device Record Key661049ea-9cdb-47ab-b8d2-5aa8fa92b3a4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient-Fitted TMJ Reconstructive Prosthesis System
Version Model Number61-2314
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
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
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
GS107613327626810 [Primary]
HIBCCB0046123140 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZDJoint, Temporomandibular, Implant

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

[07613327626810]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-19
Device Publish Date2023-09-11

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

B004YYMMDDNNNNRM0Right Mandibular Component
B004YYMMDDNNNNRF0Right Fossa Component
B004YYMMDDNNNNM0Anatomical Bone Model
B004YYMMDDNNNNLM0Left Mandibular Component
B004YYMMDDNNNNLF0Left Fossa Component
07613327627800Anatomical Bone Model, Accessory
07613327627787Anatomical Bone Model, Accessory
07613327627770Anatomical Bone Model, Accessory
07613327627763Anatomical Bone Model, Accessory
076133276269262.0 x 14 mm Self-Tapping Bone Screw
076133276269192.3 x 8 mm Self-Tapping Bone Screw, 5 Pack
076133276269022.3 x 14 mm Self-Tapping Bone Screw, 5 Pack
076133276268962.3 x 6 mm Self-Tapping Bone Screw
076133276268892.3 x 12 mm Self-Tapping Bone Screw
076133276268722.3 x 16 mm Self-Tapping Bone Screw, 5 Pack
076133276268652.3 x 10 mm Self-Tapping Bone Screw, 5 Pack
076133276268582.3 x 12 mm Self-Tapping Bone Screw, 5 Pack
076133276268412.3 x 6 mm Self-Tapping Bone Screw, 5 Pack
076133276268342.3 x 16 mm Self-Tapping Bone Screw
076133276268272.3 x 8 mm Self-Tapping Bone Screw
076133276268102.3 x 14 mm Self-Tapping Bone Screw
076133276268032.3 x 10 mm Self-Tapping Bone Screw
076133276267972.0 x 10 mm Self-Tapping Bone Screw, 5 Pack
076133276267802.0 x 14 mm Self-Tapping Bone Screw, 5 Pack
076133276267732.0 x 5 mm Self-Tapping Bone Screw
076133276267662.0 x 12 mm Self-Tapping Bone Screw, 5 Pack
076133276267592.0 x 16 mm Self-Tapping Bone Screw, 5 Pack
076133276267422.0 x 10 mm Self-Tapping Bone Screw
07613327626735Sterilization Case Instrument Base
076133276267282.0 x 8 mm Self-Tapping Bone Screw, 5 Pack
076133276267112.0 x 6 mm Self-Tapping Bone Screw, 5 Pack
076133276267042.0 x 16 mm Self-Tapping Bone Screw
076133276266982.0 x 8 mm Self-Tapping Bone Screw
076133276266812.0 x 5 mm Self-Tapping Bone Screw, 5 Pack
076133276266742.0 x 12 mm Self-Tapping Bone Screw
07613327626667Sterilization Case Screw Base
076133276266502.0 x 6 mm Self-Tapping Bone Screw
07613327626643Implant Stabilizer
07613327626636Sterilization Case Lid
07613327626629Fossa Seating Tool
07613327626612Pilot Drill 2.0mm
07613327626605TMJ Unilateral Implants, Oversized
07613327626599Pilot Drill 2.3mm
07613327626582Drill Guide
07613327626575TMJ Bilateral Implants
07613327626568TMJ Bilateral Implants, Oversized
07613327626551TMJ Unilateral Implants
07613327626544Mandibular Forceps
07613327626537Driver Blade
07613327626520TMJ Driver Handle and Blade (Loaner)
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