Level ONE Neuro
Burr Hole Cover, LOW Profile, 5.0 MM Opening, Contoured, Neuro Screw, CP Titanium
3manufacturers in China registered for this device type
253catalogue numbers in this listing
19510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Shanghai (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 4 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2022-02-22 |
| Record revised | 2025-04-11 (version 10) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 25-153-55-09 | 1.5 X 5 MM | 5 | In distribution |
| 50-312-01-09 | 6 HOLE, T=0.6 MM | In distribution | |
| 50-310-31-09 | 5 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 25-304-85-91 | 4 HOLE, 20 MM, T=0.6 MM | In distribution | |
| 25-016-11-09 | 5 X 2 HOLES, 43 MM, T=0.6 MM | In distribution | |
| 25-153-94-09 | 12 HOLE, 94 MM, T=0.6 MM | In distribution | |
| 25-153-25-09 | 6 HOLE, 23 MM DIA, T=0.35 MM | In distribution | |
| 25-780-04-91 | 1.5 X 4 MM | In distribution | |
| 25-153-32-09 | 3 X 2 HOLES, 15 MM, T=0.35 MM | In distribution | |
| 50-310-23-09 | 5 HOLE, 12 MM DIA, T=0.3 MM | In distribution | |
| 50-310-13-09 | 6 HOLE, 12 MM DIA, T=0.5 MM | In distribution | |
| 25-316-00-91 | 16 HOLE, 63 MM, T=0.6 MM | In distribution | |
| 25-012-01-09 | 53 X 43 MM, T=0.3 MM | In distribution | |
| 25-007-12-09 | 120 X 120 MM, T=0.3 MM | In distribution | |
| 25-153-54-09 | 1.5 X 4 MM | 5 | In distribution |
| 50-312-05-09 | 2 HOLE, 13 MM, T=0.6 MM | In distribution | |
| 99-576-76-01 | 1.5 X 4 MM | In distribution | |
| 01-007-12-09 | 5 HOLE, 18 MM DIA, T=0.5 MM | In distribution | |
| 01-801-12-09 | 105 X 105 MM, T=1.0 MM | In distribution | |
| 25-042-11-09 | 45 X 25 MM, T=0.6 MM | In distribution | |
| 25-153-02-09 | 2 HOLE, 14 MM, T=0.35 MM | In distribution | |
| 25-007-15-09 | 135 X 120 MM, T=0.6 MM | In distribution | |
| 50-338-05-91 | 1.5 X 5 MM | In distribution | |
| 25-320-71-09 | 5 HOLE, 17 MM, T=0.6 MM | In distribution | |
| 99-574-06-03 | 6 HOLE, 23 MM DIA, T=0.5 MM | In distribution | |
| 25-042-06-09 | T=0.2 MM | In distribution | |
| 25-006-54-09 | 60 X 50 MM, T=0.6 MM | In distribution | |
| 25-003-11-09 | 84 X 53 MM, T=0.3 MM | In distribution | |
| 99-576-76-58 | 1.8 X 5 MM | 5 | In distribution |
| 25-003-15-09 | 5 HOLE, 12 MM DIA, T=0.3 MM | In distribution | |
| 25-302-13-09 | 2 HOLE, 15 MM, T=0.6 MM | In distribution | |
| 99-576-76-56 | 1.8 X 4 MM | 5 | In distribution |
| 25-008-77-09 | 170 X 138 MM, T=1.0 MM | In distribution | |
| 50-338-05-61 | 1.5 X 5 MM | In distribution | |
| 50-311-28-09 | 6 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 99-566-02-01 | 12 HOLE, 94 MM, T=0.6 MM | In distribution | |
| 25-009-10-09 | 169 X 163 MM, T=0.6 MM | In distribution | |
| 25-153-12-09 | 2 HOLE, 17 MM, T=0.35 MM | In distribution | |
| 50-310-27-09 | 5 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 25-016-08-09 | 4 X 2 HOLES, 30 MM, T=1.0 MM | In distribution | |
| 01-040-16-09 | 53 X 43 MM, T=0.3 MM | In distribution | |
| 25-015-08-09 | 4 X 2 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 25-008-74-09 | 100 MM DIA, T=0.8 MM | In distribution | |
| 25-153-07-09 | 5 HOLE, 19 MM, T=0.35 MM | In distribution | |
| 25-006-53-09 | 63 MM, T=0.6 MM | In distribution | |
| 25-008-71-09 | 75 MM DIA, T=0.6 MM | In distribution | |
| 25-316-01-09 | 16 HOLE, 63 MM, T=0.6 MM | In distribution | |
| 25-006-44-09 | 44 X 28 MM, T=0.6 MM | In distribution | |
| 25-003-25-09 | 5 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-004-70-09 | 73 MM DIA, T=0.6 MM | In distribution | |
| 99-576-76-07 | 1.5 X 5 MM | In distribution | |
| 25-153-22-09 | 2 X 2 HOLES, 14 MM, T=0.35 MM | In distribution | |
| 25-042-03-09 | 32 X 28 MM, T=0.2 MM | In distribution | |
| 25-003-21-09 | 5 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 25-003-18-09 | 100 X 100 MM, T=0.3 MM | In distribution | |
| 25-153-04-61 | 1.5 X 4 MM | In distribution | |
| 25-781-04-91 | 1.8 X 4 MM | In distribution | |
| 25-153-53-09 | 1.5 X 3.5 MM | 5 | In distribution |
| 25-008-72-09 | 75 MM DIA, T=0.8 MM | In distribution | |
| 25-009-03-09 | 130 X 125 MM, T=0.6 MM | In distribution | |
| 995-5935-01 | 7 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-003-14-09 | 2 X 2 HOLES, T=0.3 MM | In distribution | |
| 99-566-02-02 | 12 HOLE, 94 MM, T=0.6 MM | In distribution | |
| 50-338-04-91 | 1.5 X 4 MM | In distribution | |
| 50-310-32-09 | 5 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-040-27-09 | 61 X 40 MM, T=0.3 MM | In distribution | |
| 50-310-21-09 | 5 HOLE, 18 MM DIA, T=0.6 MM | In distribution | |
| 25-008-70-09 | 49 MM DIA, T=0.6 MM | In distribution | |
| 25-153-34-09 | 57 MM DIA, T=0.35 MM | In distribution | |
| 25-003-16-09 | 3 X 2 HOLES, T=0.3 MM | In distribution | |
| 25-304-86-09 | 4 HOLE, 20 MM, T=0.6 MM | In distribution | |
| 25-781-03-91 | 1.8 X 3.5 MM | In distribution | |
| 25-780-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 25-005-10-09 | 84 X 53 MM, T=0.6 MM | In distribution | |
| 25-007-04-09 | 89 X 85 MM, T=0.6 MM | In distribution | |
| 50-310-26-09 | 5 HOLE, 26 MM DIA, T=0.3 MM | In distribution | |
| 25-006-51-09 | 63 MM, T=0.6 MM | In distribution | |
| 01-302-13-09 | 2 HOLE, 13 MM, T=0.6 MM | In distribution | |
| 25-003-13-09 | 83 X 47 MM, T=0.3 MM | In distribution | |
| 25-153-06-09 | 6 HOLE, 18 MM, T=0.35 MM | In distribution | |
| 25-153-20-09 | 5 HOLE, 18 MM DIA, T=0.35 MM | In distribution | |
| 01-007-15-09 | 5 HOLE, 17 MM DIA, T=0.3 MM | In distribution | |
| 50-338-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 25-153-08-09 | 6 HOLE, 27 MM, T=0.35 MM | In distribution | |
| 25-008-20-09 | 200 X 200 MM, T=0.6 MM | In distribution | |
| 25-780-03-09 | 1.5 X 3.5 MM | 5 | In distribution |
| 25-003-05-09 | 5 HOLE, T=0.3 MM | In distribution | |
| 25-008-85-09 | 68 X 61 MM, T=0.6 MM | In distribution | |
| 01-310-30-09 | 5 HOLE, 26 MM DIA, T=0.3 MM | In distribution | |
| 25-007-40-09 | 271 X 163 MM, T=0.6 MM | In distribution | |
| 25-006-45-09 | 61 X 38 MM, T=0.6 MM | In distribution | |
| 25-003-44-09 | 4 HOLE, T=0.3 MM | In distribution | |
| 25-153-55-61 | 1.5 X 5 MM | In distribution | |
| 50-310-37-09 | 2 HOLE, 17 MM DIA, T=0.3 MM | In distribution | |
| 99-574-06-02 | 6 HOLE, 17 MM DIA, T=0.5 MM | In distribution | |
| 25-780-03-91 | 1.5 X 3.5 MM | In distribution | |
| 99-574-06-01 | 6 HOLE, 12 MM DIA, T=0.5 MM | In distribution | |
| 25-008-76-09 | 125 MM DIA, T=1.0 MM | In distribution | |
| 99-576-76-06 | 1.8 X 4 MM | In distribution | |
| 25-004-25-09 | 160 X 135 MM, T=0.6 MM | In distribution | |
| 25-153-05-61 | 1.5 X 5 MM | In distribution | |
| 99-576-76-55 | 1.5 X 3.5 MM | 5 | In distribution |
| 99-576-76-08 | 1.8 X 5 MM | In distribution | |
| 25-153-53-61 | 1.5 X 3.5 MM | In distribution | |
| 25-153-01-09 | 4 HOLE, 14 MM, T=0.35 MM | In distribution | |
| 25-005-12-09 | 80 X 53 MM, T=0.3 MM | In distribution | |
| 25-006-50-09 | 42 MM, T=0.6 MM | In distribution | |
| 25-003-06-09 | 6 HOLE, T=0.3 MM | In distribution | |
| 25-153-85-09 | 83 X 47 MM, T=0.35 MM | In distribution | |
| 25-006-55-09 | 68 X 38 MM, T=0.6 MM | In distribution | |
| 25-302-12-91 | 2 HOLE, 15 MM, T=0.6 MM | In distribution | |
| 25-781-03-09 | 1.8 X 3.5 MM | 5 | In distribution |
| 25-322-70-91 | 6 HOLE, 16 MM, T=0.6 MM | In distribution | |
| 99-576-76-05 | 1.5 X 3.5 MM | In distribution | |
| 50-310-57-09 | 5 HOLE, 18 MM DIA, T=0.5 MM | In distribution | |
| 25-008-90-09 | 68 X 61 MM, T=0.6 MM | In distribution | |
| 50-310-28-09 | 5 HOLE, 17 MM DIA, T=0.3 MM | In distribution | |
| 25-042-01-09 | T=0.2 MM | In distribution | |
| 25-320-70-91 | 5 HOLE, 17 MM, T=0.6 MM | In distribution | |
| 25-153-53-91 | 1.5 X 3.5 MM | In distribution | |
| 50-310-01-09 | 3.0 MM STEP, T=1.0 MM | In distribution | |
| 25-007-11-09 | 167 X 124 MM, T=0.6 MM | In distribution | |
| 25-016-06-09 | 3 X 2 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-007-06-09 | 105 X 66 MM, T=0.6 MM | In distribution | |
| 99-576-76-57 | 1.5 X 5 MM | 5 | In distribution |
| 25-153-54-61 | 1.5 X 4 MM | In distribution | |
| 50-310-33-09 | 5 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-781-04-09 | 1.8 X 4 MM | 5 | In distribution |
| 50-310-14-09 | 6 HOLE, 17 MM DIA, T=0.5 MM | In distribution | |
| 25-009-02-09 | 130 X 125 MM, T=0.6 MM | In distribution | |
| 50-310-22-09 | 5 HOLE, 12 MM DIA, T=0.3 MM | In distribution | |
| 25-153-33-09 | 46 MM DIA, T=0.35 MM | In distribution | |
| 50-310-05-09 | 5 HOLE, 18 MM DIA, T=0.5 MM | In distribution | |
| 50-310-18-09 | 5 HOLE, 18 MM DIA, T=0.6 MM | In distribution | |
| 25-015-05-09 | 2 X 2 HOLES, 9 MM, T=0.6 MM | In distribution | |
| 25-003-07-09 | 5 HOLE, T=0.3 MM | In distribution | |
| 01-040-17-09 | 60 X 53 MM, T=0.3 MM | In distribution | |
| 50-310-08-09 | 5 HOLE, 18 MM DIA, T=0.6 MM | In distribution | |
| 25-153-54-91 | 1.5 X 4 MM | In distribution | |
| 50-311-29-09 | 6 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 50-310-36-09 | 7 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-153-95-09 | 12 HOLE, 94 MM, T=0.6 MM | In distribution | |
| 25-003-04-09 | 4 HOLE, T=0.3 MM | In distribution | |
| 25-042-02-09 | 40 X 32 MM, T=0.2 MM | In distribution | |
| 25-304-00-91 | 4 HOLE, 15 MM, T=0.6 MM | In distribution | |
| 50-312-07-09 | 2 HOLE, 16 MM, T=0.6 MM | In distribution | |
| 25-016-10-09 | 5 X 2 HOLES, 43 MM, T=0.6 MM | In distribution | |
| 50-312-04-09 | 2 HOLE, 16 MM, T=0.6 MM | In distribution | |
| 25-007-01-09 | 85 X 75 MM, T=0.6 MM | In distribution | |
| 25-007-05-09 | 89 X 85 MM, T=0.6 MM | In distribution | |
| 99-576-76-02 | 1.5 X 5 MM | In distribution | |
| 25-003-08-09 | 8 HOLE, T=0.3 MM | In distribution | |
| 25-009-11-09 | 169 X 163 MM, T=0.6 MM | In distribution | |
| 25-012-02-09 | 60 X 53 MM, T=0.3 MM | In distribution | |
| 25-007-10-09 | 167 X 124 MM, T=0.6 MM | In distribution | |
| 50-338-04-61 | 1.5 X 4 MM | In distribution | |
| 50-310-35-09 | 5 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-006-12-09 | 80 X 53 MM, T=0.6 MM | In distribution | |
| 995-3523-01-1 | 163 X 42 MM, T=0.6 MM | In distribution | |
| 25-010-20-09 | 200 X 200 MM, T=1.0 MM | In distribution | |
| 25-006-52-09 | 42 MM, T=0.6 MM | In distribution | |
| 50-338-05-09 | 1.5 X 5 MM | 5 | In distribution |
| 25-015-07-09 | 3 X 2 HOLES, 21 MM, T=0.6 MM | In distribution | |
| 25-007-14-09 | 190 X 130 MM, T=0.6 MM | In distribution | |
| 25-775-04-91 | 1.5 X 4 MM | In distribution | |
| 25-006-10-09 | 100 X 100 MM, T=0.6 MM | In distribution | |
| 25-008-73-09 | 100 MM DIA, T=0.6 MM | In distribution | |
| 25-009-80-09 | 80 X 80 MM, T=1.0 MM | In distribution | |
| 25-007-07-09 | 105 X 87 MM, T=0.6 MM | In distribution | |
| 25-042-05-09 | 34 X 21 MM, T=0.2 MM | In distribution | |
| 50-310-62-09 | 5 HOLE, 22 MM DIA, T=0.5 MM | In distribution | |
| 25-153-15-09 | 5 HOLE, 12 MM DIA, T=0.35 MM | In distribution | |
| 50-312-02-09 | 4 HOLE, T=0.6 MM | In distribution | |
| 25-322-71-09 | 6 HOLE, 16 MM, T=0.6 MM | In distribution | |
| 25-008-75-09 | 100 MM DIA, T=1.0 MM | In distribution | |
| 25-042-04-09 | 45 X 21 MM, T=0.2 MM | In distribution | |
| 25-015-06-09 | 3 X 2 HOLES, 21 MM, T=0.6 MM | In distribution | |
| 25-007-50-09 | 50 X 50 MM, T=0.3 MM | In distribution | |
| 25-013-04-09 | 2 X 2 HOLES, 14 MM, T=0.6 MM | In distribution | |
| 25-007-80-09 | 80 X 80 MM, T=0.3 MM | In distribution | |
| 25-008-50-09 | 50 X 50 MM, T=0.6 MM | In distribution | |
| 25-044-12-09 | 85 X 53 MM, T=0.3 MM | In distribution | |
| 25-153-14-09 | 4 HOLE, 22 MM, T=0.35 MM | In distribution | |
| 50-310-11-09 | 5 HOLE, 18 MM DIA, T=0.6 MM | In distribution | |
| 25-008-12-09 | 120 X 120 MM, T=0.6 MM | In distribution | |
| 50-310-19-09 | 5 HOLE, 18 MM DIA, T=0.6 MM | In distribution | |
| 25-153-03-61 | 1.5 X 3.5 MM | In distribution | |
| 25-006-43-09 | 53 X 33 MM, T=0.6 MM | In distribution | |
| 25-010-12-09 | 120 X 120 MM, T=1.0 MM | In distribution | |
| 25-008-80-09 | 80 X 80 MM, T=0.6 MM | In distribution | |
| 25-153-44-61 | 1.8 X 4 MM | In distribution | |
| 25-153-21-09 | 6 HOLE, 18 MM DIA, T=0.35 MM | In distribution | |
| 25-003-70-09 | 2 HOLE, 12 MM, T=0.3 MM | In distribution | |
| 99-576-76-51 | 1.5 X 4 MM | 5 | In distribution |
| 01-802-01-09 | 57 X 47 MM, T=0.6 MM | In distribution | |
| 50-312-06-09 | 2 HOLE, 18 MM, T=0.6 MM | In distribution | |
| 25-014-10-09 | 5 X 2 HOLES, 43 MM, T=0.6 MM | In distribution | |
| 25-302-71-09 | 2 HOLE, 10 MM, T=0.6 MM | In distribution | |
| 25-003-10-09 | 84 X 53 MM, T=0.3 MM | In distribution | |
| 50-311-27-09 | 5 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 25-007-08-09 | 77 X 68 MM, T=0.6 MM | In distribution | |
| 25-302-70-91 | 2 HOLE, 10 MM, T=0.6 MM | In distribution | |
| 25-153-45-61 | 1.8 X 5 MM | In distribution | |
| 25-015-09-09 | 4 X 2 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 25-007-09-09 | 77 X 68 MM, T=0.6 MM | In distribution | |
| 25-042-10-09 | 32 X 18 MM, T=0.6 MM | In distribution | |
| 25-007-03-09 | 95 X 83 MM, T=0.6 MM | In distribution | |
| 25-040-26-09 | 54 X 36 MM, T=0.3 MM | In distribution | |
| 25-004-90-09 | 100 MM DIA, T=0.6 MM | In distribution | |
| 25-016-07-09 | 3 X 2 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-040-25-09 | 85 X 54 MM, T=0.2 MM | In distribution | |
| 25-003-12-09 | 2 HOLE, 17 MM, T=0.3 MM | In distribution | |
| 25-014-04-09 | 2 X 2 HOLES, 12 MM, T=0.6 MM | In distribution | |
| 25-304-01-09 | 4 HOLE, 15 MM, T=0.6 MM | In distribution | |
| 50-310-15-09 | 6 HOLE, 23 MM DIA, T=0.5 MM | In distribution | |
| 25-015-04-09 | 2 X 2 HOLES, 12 MM, T=0.6 MM | In distribution | |
| 50-310-52-09 | 5 HOLE, 12 MM DIA, T=0.5 MM | In distribution | |
| 25-004-50-09 | 45 MM DIA, T=0.6 MM | In distribution | |
| 25-003-17-09 | 5 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 50-310-42-09 | 2 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-153-55-91 | 1.5 X 5 MM | In distribution | |
| 50-311-25-09 | 6 HOLE, 12 MM DIA, T=0.3 MM | In distribution | |
| 25-007-02-09 | 95 X 83 MM, T=0.6 MM | In distribution | |
| 25-775-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 25-007-13-09 | 190 X 130 MM, T=0.6 MM | In distribution | |
| 25-003-28-09 | 18 HOLE, T=0.3 MM | In distribution | |
| 995-5418-02-91 | 1.6 X 4 MM | Withdrawn | |
| 995-5211-01 | 5 HOLE, 22 MM DIA, T=0.3 MM | Withdrawn | |
| 50-309-25-09 | 5 HOLE, 15 MM DIA, T=0.3 MM | Withdrawn | |
| 01-040-15-09 | 53 X 43 MM, T=0.2 MM | Withdrawn | |
| 25-780-04-61 | 1.5 X 4 MM | Withdrawn | |
| 50-309-12-09 | 5 HOLE, 12 MM DIA, T=0.6 MM | Withdrawn | |
| 995-3009-01 | 105 X 105 MM, T=0.6 MM | Withdrawn | |
| 25-780-03-61 | 1.5 X 3.5 MM | Withdrawn | |
| 01-310-32-09 | 5 HOLE, 29 MM DIA, T=0.3 MM | Withdrawn | |
| 995-3207-02-1 | 5 HOLE, 22 MM DIA, T=0.5 MM | Withdrawn | |
| 50-309-22-09 | 5 HOLE, 12 MM DIA, T=0.3 MM | Withdrawn | |
| 995-3207-01-1 | 5 HOLE, 18 MM DIA, T=0.5 MM | Withdrawn | |
| 995-5419-04 | 130 X 125 MM, T=0.6 MM | Withdrawn | |
| 99-576-76-03 | 1.8 X 4 MM | Withdrawn | |
| 01-040-18-09 | 52 X 43 MM, T=0.3 MM | Withdrawn | |
| 01-300-22-91 | 8 HOLE, 21 MM DIA, T=0.4 MM | Withdrawn | |
| 01-016-06-09 | 3 X 2 HOLES, 23 MM, T=0.6 MM | Withdrawn | |
| 01-310-27-09 | 5 HOLE, 18 MM DIA, T=0.3 MM | Withdrawn | |
| 25-781-04-61 | 1.8 X 4 MM | Withdrawn | |
| 01-300-21-91 | 4 HOLE, 21 MM DIA, T=0.4 MM | Withdrawn | |
| 995-5419-02 | 130 X 125 MM, T=0.6 MM | Withdrawn | |
| 995-5419-03 | 169 X 163 MM, T=0.6 MM | Withdrawn | |
| 995-5419-01 | 169 X 163 MM, T=0.6 MM | Withdrawn | |
| 01-310-22-09 | 5 HOLE, 12 MM DIA, T=0.3 MM | Withdrawn |
Showing 250 of 253 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| Level ONE CMF | KLS-Martin L.P. | 1,160 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 843 |
| OsteoMed | Osteomed | 675 |
| Bioplate® | Bioplate, Inc. | 669 |
| Plate, Bone | Synthes Gmbh | 568 |
| Leforte System Bone Plate | Jeil Medical Corporation | 466 |
| CMF Visionare | Visionare LLC | 421 |
| Level ONE CMF, Sterile | KLS-Martin L.P. | 416 |
| Faico CMF System | Faico Medical, LLC | 361 |
| TraumaOne System | Biomet Microfixation | 357 |
| MatrixMANDIBLE | Synthes Gmbh | 277 |
Showing 12 of 152. All products under Plate, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260137 | 2026-08-17 |
| K241314 | 2024-08-16 |
| K210731 | 2022-07-18 |
| K191028 | 2019-11-22 |
| K180962 | 2018-08-13 |
| K173320 | 2018-02-23 |
| K163579 | 2017-11-21 |
| K133304 | 2014-05-15 |
| K112064 | 2012-03-23 |
| K080862 | 2008-07-21 |
| K061507 | 2006-09-21 |
| K060177 | 2006-04-18 |
| K051236 | 2005-08-22 |
| K011590 | 2002-03-20 |
| K003883 | 2001-01-23 |
| K994154 | 2000-02-15 |
| K944565 | 1994-10-18 |
| K944561 | 1994-10-18 |
| K944560 | 1994-10-18 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.