stryker.comPatient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 14 mm Self-Tapping Bone Screw
2023-09-11
TMJ Solutions, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2031049 | 3001237463 | TMJ Solutions, LLC | 1 | N | 2026-01-01 | 6059 King Drive San Buenaventura CA US 93003 |
| 2031049 | 3001237463 | TMJ Solutions, Inc | 1 | N | 2020-04-25 | 6059 King Drive San Buenaventura CA US 93003 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07613327626834 | Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 16 mm Self-Tapping Bone Screw | 805-650-3391 | lorena.lundeen@stryker.com |
| 07613327626841 | Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 6 mm Self-Tapping Bone Screw, 5 Pack | 805-650-3391 | lorena.lundeen@stryker.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 53885 | 1428696762 | P980052 | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | LZD | 1999-07-02 |
| 53885 | 1692795475 | ||||
| 291666 | 1406486892 | ||||
| 291666 | 1506767828 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LZD | 1 | 1999-07-02 |
GUDID#
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 16 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 6 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 12 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 10 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 16 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 12 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 6 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 14 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 8 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - TMJ Unilateral Implants
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Patient-Fitted TMJ Reconstructive Prosthesis System - Anatomical Bone Model, Accessory
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - Anatomical Bone Model, Accessory
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - Anatomical Bone Model, Accessory
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - Anatomical Bone Model, Accessory
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - Left Fossa Component
2021-11-10
Patient-Fitted TMJ Reconstructive Prosthesis System - Left Mandibular Component
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Patient-Fitted TMJ Reconstructive Prosthesis System - Anatomical Bone Model
2021-11-10
Patient-Fitted TMJ Reconstructive Prosthesis System - Right Fossa Component
2021-11-10
Patient-Fitted TMJ Reconstructive Prosthesis System - Right Mandibular Component
2021-11-10
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 14 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - TMJ Bilateral Implants, Oversized
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Patient-Fitted TMJ Reconstructive Prosthesis System - TMJ Bilateral Implants
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Patient-Fitted TMJ Reconstructive Prosthesis System - TMJ Unilateral Implants, Oversized
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 6 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 12 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 5 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 8 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 16 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 6 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 10 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 16 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 12 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 5 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 14 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 10 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 10 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.3 x 8 mm Self-Tapping Bone Screw
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - 2.0 x 8 mm Self-Tapping Bone Screw, 5 Pack
2023-09-11
Patient-Fitted TMJ Reconstructive Prosthesis System - Anatomical Bone Model
2017-01-27