Joint, Temporomandibular, Implant
Regulation 872.3940
0510(k)s in 12 months (0 all time)
2recalls in 12 months (20 all time)
0recalls that name a 510(k)
Top companies in LZD
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet Microfixation, LLC | 0 | 15 |
| TMJ Solutions Inc | 0 | 4 |
| Stryker Leibinger GmbH & Co. KG | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2026 | TMJ Solutions Inc TMJ Bilateral Implants, REF: CHG020 Open, Classified |
LZD | None listed |
| Nov 14, 2025 | TMJ Solutions Inc TMJ Bilateral Implant
REF: CHG020
Sterile EO, Rx Only Open, Classified |
LZD | None listed |
| Sep 26, 2024 | TMJ Solutions Inc Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Man Open, Classified |
LZD | None listed |
| Mar 8, 2023 | Stryker Leibinger GmbH & Co. KG Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Open, Classified |
LZD | None listed |
| Apr 19, 2018 | TMJ Solutions Inc Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM
The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthe Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand
Reconstruction of the temporomandibular joint Terminated |
LZD | None listed |
| Dec 16, 2014 | Biomet Microfixation, LLC Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand Terminated |
LZD | None listed |
| Sep 2, 2014 | Biomet Microfixation, LLC Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506
The Total Temporomandibular Joint (TMJ) replacement system is implanted in the jaw to functionally recons Terminated |
LZD | None listed |
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