Level ONE Neuro, Sterile
KIT, Craniotomy Flap, 25-975-04-71 (6), 01-302-13-71 (3), CP Titanium / TI-6AL-4V
3manufacturers in China registered for this device type
115catalogue 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 | 2017-03-23 |
| Record revised | 2025-06-09 (version 10) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 25-975-05-70 | 1.5 X 5 MM | 10 | In distribution |
| 25-006-53-71 | 63 MM, T=0.6 MM | In distribution | |
| 25-008-20-71 | 200 X 200 MM, T=0.6 MM | In distribution | |
| 25-007-05-71 | 89 X 85 MM, T=0.6 MM | In distribution | |
| 25-975-03-70 | 1.5 X 3.5 MM | 10 | In distribution |
| 25-153-05-72 | 1.5 X 5 MM | 2 | In distribution |
| 25-040-25-71 | 84 X 53 MM, T=0.2 MM | In distribution | |
| 25-976-04-71 | 1.8 X 4 MM | In distribution | |
| 25-153-08-71 | 6 HOLE, 27 MM, T=0.35 MM | In distribution | |
| 25-007-09-71 | 77 X 68 MM, T=0.6 MM | In distribution | |
| 25-007-03-71 | 95 X 83 MM, T=0.6 MM | In distribution | |
| 25-975-04-75 | 1.5 X 4 MM | 5 | In distribution |
| 25-153-05-70 | 1.5 X 5 MM | 10 | In distribution |
| 25-007-15-71 | 135 X 120 MM, T=0.6 MM | In distribution | |
| 25-153-15-71 | 5 HOLE, 12 MM DIA, T=0.35 MM | In distribution | |
| 25-976-05-71 | 1.8 X 5 MM | In distribution | |
| 25-153-55-78 | 1.5 X 5 MM | 8 | In distribution |
| 25-975-04-76 | 1.5 X 4 MM | 6 | In distribution |
| 25-007-06-71 | 105 X 66 MM, T=0.6 MM | In distribution | |
| 25-007-02-71 | 95 X 83 MM, T=0.6 MM | In distribution | |
| 25-007-14-71 | 190 X 130 MM, T=0.6 MM | In distribution | |
| 25-153-22-71 | 2 X 2 HOLES, 14 MM, T=0.35 MM | In distribution | |
| 25-153-55-71 | 1.5 X 5 MM | In distribution | |
| 25-153-06-71 | 6 HOLE, 18 MM, T=0.35 MM | In distribution | |
| 25-008-74-71 | 100 MM DIA, T=0.8 MM | In distribution | |
| 25-006-50-71 | 42 MM, T=0.6 MM | In distribution | |
| 25-153-44-71 | 1.8 X 4 MM | In distribution | |
| 25-153-20-71 | 5 HOLE, 18 MM DIA, T=0.35 MM | In distribution | |
| 25-302-13-71 | 2 HOLE, 15 MM, T=0.6 MM | In distribution | |
| 25-008-76-71 | 125 MM DIA, T=1.0 MM | In distribution | |
| 25-008-70-71 | 49 MM DIA, T=0.6 MM | In distribution | |
| 25-153-85-71 | 83 X 47 MM, T=0.35 MM | In distribution | |
| 25-006-45-71 | 61 X 38 MM, T=0.6 MM | In distribution | |
| 25-003-10-71 | 84 X 53 MM, T=0.3 MM | In distribution | |
| 25-007-13-71 | 190 X 130 MM, T=0.6 MM | In distribution | |
| 25-153-53-78 | 1.5 X 3.5 MM | 8 | In distribution |
| 25-007-10-71 | 167 X 124 MM, T=0.6 MM | In distribution | |
| 25-015-05-71 | 2 X 2 HOLES, 9 MM, T=0.6 MM | In distribution | |
| 25-153-21-71 | 6 HOLE, 18 MM DIA, T=0.35 MM | In distribution | |
| 25-006-43-71 | 53 X 33 MM, T=0.6 MM | In distribution | |
| 99-594-33-01 | In distribution | ||
| 25-153-01-71 | 4 HOLE, 14 MM, T=0.35 MM | In distribution | |
| 25-008-72-71 | 75 MM DIA, T=0.8 MM | In distribution | |
| 25-153-02-71 | 2 HOLE, 14 MM, T=0.35 MM | In distribution | |
| 25-010-12-71 | 120 X 120 MM, T=1.0 MM | In distribution | |
| 25-975-04-70 | 1.5 X 4 MM | 10 | In distribution |
| 25-153-05-76 | 1.5 X 5 MM | 6 | In distribution |
| 50-310-28-71 | 5 HOLE, 17 MM DIA, T=0.3 MM | In distribution | |
| 25-153-53-71 | 1.5 X 3.5 MM | In distribution | |
| 25-015-09-71 | 4 X 2 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 25-012-01-71 | 53 X 43 MM, T=0.3 MM | In distribution | |
| 25-016-11-71 | 5 X 2 HOLES, 43 MM, T=0.6 MM | In distribution | |
| 25-153-12-71 | 2 HOLE, 17 MM, T=0.35 MM | In distribution | |
| 25-975-04-71 | 1.5 X 4 MM | In distribution | |
| 25-302-10-71 | In distribution | ||
| 01-801-12-71 | 105 X 105 MM, T=1.0 MM | In distribution | |
| 25-153-03-70 | 1.5 X 3.5 MM | 10 | In distribution |
| 25-302-71-71 | 2 HOLE, 10 MM, T=0.6 MM | In distribution | |
| 25-010-20-71 | 200 X 200 MM, T=1.0 MM | In distribution | |
| 25-153-54-78 | 1.5 X 4 MM | 8 | In distribution |
| 25-153-32-71 | 3 X 2 HOLES, 15 MM, T=0.35 MM | In distribution | |
| 25-316-01-71 | 16 HOLE, 63 MM, T=0.6 MM | In distribution | |
| 25-008-80-71 | 80 X 80 MM, T=0.6 MM | In distribution | |
| 25-008-12-71 | 120 X 120 MM, T=0.6 MM | In distribution | |
| 25-153-04-76 | 1.5 X 4 MM | 6 | In distribution |
| 25-006-52-71 | 42 MM, T=0.6 MM | In distribution | |
| 25-320-71-71 | 5 HOLE, 17 MM, T=0.6 MM | In distribution | |
| 25-007-01-71 | 85 X 75 MM, T=0.6 MM | In distribution | |
| 25-153-04-70 | 1.5 X 4 MM | 10 | In distribution |
| 25-008-75-71 | 100 MM DIA, T=1.0 MM | In distribution | |
| 25-975-05-76 | 1.5 X 5 MM | 6 | In distribution |
| 25-975-05-71 | 1.5 X 5 MM | In distribution | |
| 25-153-03-72 | 1.5 X 3.5 MM | 2 | In distribution |
| 25-003-11-71 | 84 X 53 MM, T=0.3 MM | In distribution | |
| 25-015-04-71 | 2 X 2 HOLES, 12 MM, T=0.6 MM | In distribution | |
| 25-153-04-72 | 1.5 X 4 MM | 2 | In distribution |
| 25-007-07-71 | 105 X 87 MM, T=0.6 MM | In distribution | |
| 25-153-04-71 | 1.5 X 4 MM | In distribution | |
| 01-302-13-71 | 2 HOLE, 13 MM, T=0.6 MM | In distribution | |
| 25-015-07-71 | 3 X 2 HOLES, 21 MM, T=0.6 MM | In distribution | |
| 25-975-04-72 | 1.5 X 4 MM | 2 | In distribution |
| 25-975-05-72 | 1.5 X 5 MM | 2 | In distribution |
| 25-153-03-71 | 1.5 X 3.5 MM | In distribution | |
| 25-153-55-74 | 1.5 X 5 MM | 4 | In distribution |
| 25-153-03-76 | 1.5 X 3.5 MM | 6 | In distribution |
| 25-003-17-71 | 5 HOLE, 18 MM DIA, T=0.3 MM | In distribution | |
| 25-975-03-76 | 1.5 X 3.5 MM | 6 | In distribution |
| 25-008-73-71 | 100 MM DIA, T=0.6 MM | In distribution | |
| 25-153-53-74 | 1.5 X 3.5 MM | 4 | In distribution |
| 25-153-14-71 | 4 HOLE, 22 MM, T=0.35 MM | In distribution | |
| 25-153-54-71 | 1.5 X 4 MM | In distribution | |
| 25-008-77-71 | 170 X 138 MM, T=1.0 MM | In distribution | |
| 25-007-04-71 | 89 X 85 MM, T=0.6 MM | In distribution | |
| 25-322-71-71 | 6 HOLE, 16 MM, T=0.6 MM | In distribution | |
| 25-007-08-71 | 77 X 68 MM, T=0.6 MM | In distribution | |
| 25-040-26-71 | 54 X 36 MM, T=0.3 MM | In distribution | |
| 25-975-03-72 | 1.5 X 3.5 MM | 2 | In distribution |
| 25-304-86-71 | 4 HOLE, 20 MM, T=0.6 MM | In distribution | |
| 25-006-51-71 | 63 MM, T=0.6 MM | In distribution | |
| 50-310-33-71 | 5 HOLE, 22 MM DIA, T=0.3 MM | In distribution | |
| 25-153-05-71 | 1.5 X 5 MM | In distribution | |
| 25-008-71-71 | 75 MM DIA, T=0.6 MM | In distribution | |
| 25-007-11-71 | 167 X 124 MM, T=0.6 MM | In distribution | |
| 25-006-44-71 | 44 X 28 MM, T=0.6 MM | In distribution | |
| 50-310-23-71 | 5 HOLE, 12 MM DIA, T=0.3 MM | In distribution | |
| 25-016-07-71 | 3 X 2 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-153-07-71 | 5 HOLE, 19 MM, T=0.35 MM | In distribution | |
| 25-153-45-71 | 1.8 X 5 MM | In distribution | |
| 25-012-02-71 | 60 X 53 MM, T=0.3 MM | In distribution | |
| 25-153-25-71 | 6 HOLE, 23 MM DIA, T=0.35 MM | In distribution | |
| 25-040-27-71 | 61 X 40 MM, T=0.3 MM | In distribution | |
| 25-153-54-74 | 1.5 X 4 MM | 4 | In distribution |
| 25-304-01-71 | 4 HOLE, 15 MM, T=0.6 MM | In distribution | |
| 25-975-03-71 | 1.5 X 3.5 MM | In distribution | |
| 25-302-20-71 | Withdrawn |
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.