510(k) K022890
- Device
- MODIFIED SCREW DESIGNS FOR USE WITH THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
- Applicant
- BIOPLATE, INC.
- 510(k) number
- K022890
- Product code
- JEY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-06
- Date received
- 2002-08-30
- Regulation
- 872.4760
- Classification name
- Plate, Bone
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CAROL E JONES
- Address
- 6911 Melrose Ave. Los Angeles CA US 90038 90038
FDA Registration Numbers#
- 3014937101
- 2032542
- 3005554774
- 3003394081
- 1032347
- 3007738812
- 1054986
- 9614438
- 3011824442
- 3017734069
- 3010326886
- 3015399803
- 3005515228
- 9681465
- 3015440604
- 1647149
- 2029005
- 3004187715
- 2029447
- 1825034
- 1226425
- 3030089802
- 3010155648
- 8031010
- 1066741
- 3027157194
- 3006001176
- 2027754
- 3004049923
- 8030965
- 3007923096
- 3003587896
- 1057425
- 3011423165
- 9612468
- 3025141
- 3003898943
- 1649518
- 1824199
- 3021635140
- 3010363503
- 3008791302
- 3004431266
- 1828288
- 3006017180
- 9610905
- 2530154
- 2916714
- 3003108161
- 3002807310
- 3009383407
- 8010468
- 2431866
- 1030489
- 3004464325
- 1650372
- 3009555440
- 3017521423
- 3015869121
- 1000606483
- 3011724582
- 3015212339
- 3005718816
- 3009196021
- 3014128887
- 3015876273
- 3015531529
- 3003322138
- 3013111692
- 3009555447
- 1420032
- 8010177
- 2024024
- 3010162973
- 3009551666
- 3034676720
- 3011196443
- 8010099
- 3011530718
- 3010287729
Source Documents#
Other 510(k) Records For Product Code JEY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252246 | Leforte MMF System | Jeil Medical Corporation | 2026-04-02 |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | 2025-12-19 |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | 2025-11-07 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | 2024-08-16 |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024-07-12 |
| K233874 | tmCMF Solution | Techmah Cmf | 2024-07-11 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | 2024-04-30 |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | 2024-01-13 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | 2023-09-26 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-05 |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | 2022-12-09 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | 2022-11-10 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | 2022-07-18 |
| K213777 | Stryker Resorbable Fixation System | Stryker Leibinger Micro Implants | 2022-02-04 |
Legacy Summary#
summary
FDA Review#
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