| Primary Device ID | 07613327627800 |
| NIH Device Record Key | ccbcd305-8a89-4c07-974a-3acf09a310a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Patient-Fitted TMJ Reconstructive Prosthesis System |
| Version Model Number | CHG010AM |
| Company DUNS | 035877922 |
| Company Name | TMJ Solutions, 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| B004YYMMDDNNNNRM0 | Right Mandibular Component |
| B004YYMMDDNNNNRF0 | Right Fossa Component |
| B004YYMMDDNNNNM0 | Anatomical Bone Model |
| B004YYMMDDNNNNLM0 | Left Mandibular Component |
| B004YYMMDDNNNNLF0 | Left Fossa Component |
| 07613327627800 | Anatomical Bone Model, Accessory |
| 07613327627787 | Anatomical Bone Model, Accessory |
| 07613327627770 | Anatomical Bone Model, Accessory |
| 07613327627763 | Anatomical Bone Model, Accessory |
| 07613327626926 | 2.0 x 14 mm Self-Tapping Bone Screw |
| 07613327626919 | 2.3 x 8 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626902 | 2.3 x 14 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626896 | 2.3 x 6 mm Self-Tapping Bone Screw |
| 07613327626889 | 2.3 x 12 mm Self-Tapping Bone Screw |
| 07613327626872 | 2.3 x 16 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626865 | 2.3 x 10 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626858 | 2.3 x 12 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626841 | 2.3 x 6 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626834 | 2.3 x 16 mm Self-Tapping Bone Screw |
| 07613327626827 | 2.3 x 8 mm Self-Tapping Bone Screw |
| 07613327626810 | 2.3 x 14 mm Self-Tapping Bone Screw |
| 07613327626803 | 2.3 x 10 mm Self-Tapping Bone Screw |
| 07613327626797 | 2.0 x 10 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626780 | 2.0 x 14 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626773 | 2.0 x 5 mm Self-Tapping Bone Screw |
| 07613327626766 | 2.0 x 12 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626759 | 2.0 x 16 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626742 | 2.0 x 10 mm Self-Tapping Bone Screw |
| 07613327626735 | Sterilization Case Instrument Base |
| 07613327626728 | 2.0 x 8 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626711 | 2.0 x 6 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626704 | 2.0 x 16 mm Self-Tapping Bone Screw |
| 07613327626698 | 2.0 x 8 mm Self-Tapping Bone Screw |
| 07613327626681 | 2.0 x 5 mm Self-Tapping Bone Screw, 5 Pack |
| 07613327626674 | 2.0 x 12 mm Self-Tapping Bone Screw |
| 07613327626667 | Sterilization Case Screw Base |
| 07613327626650 | 2.0 x 6 mm Self-Tapping Bone Screw |
| 07613327626643 | Implant Stabilizer |
| 07613327626636 | Sterilization Case Lid |
| 07613327626629 | Fossa Seating Tool |
| 07613327626612 | Pilot Drill 2.0mm |
| 07613327626605 | TMJ Unilateral Implants, Oversized |
| 07613327626599 | Pilot Drill 2.3mm |
| 07613327626582 | Drill Guide |
| 07613327626575 | TMJ Bilateral Implants |
| 07613327626568 | TMJ Bilateral Implants, Oversized |
| 07613327626551 | TMJ Unilateral Implants |
| 07613327626544 | Mandibular Forceps |
| 07613327626537 | Driver Blade |
| 07613327626520 | TMJ Driver Handle and Blade (Loaner) |