Level ONE CMF
Plate, Orthog, Genioplasty, DBL Y SHP, W/TAB, Inferior Holes, 2.0-2.5 MM Screw, CP Titanium
3manufacturers in China registered for this device type
1,160catalogue 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 | 2016-03-24 |
| Record revised | 2026-07-15 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
|---|---|---|---|
| 50-288-01-09 | 1.0 MM STEP, T=1.0 MM | In distribution | |
| 50-402-07-91 | 7 HOLE, T=0.6 MM | In distribution | |
| 25-332-27-09 | 6 HOLE, T=0.8 MM | In distribution | |
| 50-383-05-09 | 3 X 2 HOLES, 23 MM, T=0.7 MM | In distribution | |
| 25-673-49-91 | 2.3 X 9 MM | In distribution | |
| 25-304-23-09 | 2 X 2 HOLES, 12 MM, T=0.4 MM | In distribution | |
| 25-660-02-09 | 1.0 X 2 MM | 5 | In distribution |
| 25-875-09-61 | 1.5 X 9 MM | In distribution | |
| 25-329-06-09 | 5 HOLE, T=1.0 MM | In distribution | |
| 25-344-06-09 | 6 HOLE, T=0.6 MM | In distribution | |
| 50-408-06-91 | 6 HOLE, T=0.6 MM | In distribution | |
| 25-306-07-09 | 4 X 3 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 50-305-30-09 | 10.0 MM STEP, T=1.0 MM | In distribution | |
| 25-330-27-09 | 6 HOLE, T=0.8 MM | In distribution | |
| 25-010-08-09 | 4 X 2 HOLES, 27 MM, T=0.6 MM | In distribution | |
| 50-360-04-91 | 4 HOLE, 24 MM, T=0.6 MM | In distribution | |
| 25-660-04-09 | 1.0 X 4 MM | 5 | In distribution |
| 50-284-05-09 | 5.0 MM STEP, T=1.4 MM | In distribution | |
| 25-578-10-09 | 3 X 3 HOLES, 24 MM, T=0.8 MM | In distribution | |
| 25-765-21-09 | 1.5 X 21 MM | 5 | In distribution |
| 25-565-04-91 | 2 X 2 HOLES, 24 MM, T=1.0 MM | In distribution | |
| 25-675-05-91 | 1.5 X 5 MM | In distribution | |
| 50-285-11-09 | 11.0 MM STEP, T=1.4 MM | In distribution | |
| 25-010-06-09 | 3 X 2 HOLES, 19 MM, T=0.6 MM | In distribution | |
| 25-320-33-09 | 7 HOLE, 19 X 12 MM, T=0.6 MM | In distribution | |
| 50-399-12-09 | 12 HOLE, T=0.6 MM | In distribution | |
| 25-040-30-09 | 100 X 100 MM, T=0.2 MM | In distribution | |
| 50-280-11-09 | 11.0 MM STEP, T=1.0 MM | In distribution | |
| 25-858-07-09 | 1.5 X 7 MM | 5 | In distribution |
| 25-044-22-09 | 37 X 30 MM, T=0.4 MM | In distribution | |
| 50-283-13-09 | 13.0 MM STEP, T=1.4 MM | In distribution | |
| 25-401-40-09 | 4 X 2 HOLES, 40 MM, T=0.8 MM | In distribution | |
| 01-284-12-09 | 13.0 MM STEP, T=1.0 MM | In distribution | |
| 25-875-21-09 | 1.5 X 21 MM | 5 | In distribution |
| 25-310-07-09 | 4 X 3 HOLES, 24 MM, T=1.0 MM | In distribution | |
| 25-197-07-09 | 7 HOLE, 110 MM, T=0.5 MM | In distribution | |
| 50-280-09-09 | 9.0 MM STEP, T=1.0 MM | In distribution | |
| 25-320-32-09 | 7 HOLE, 19 X 12 MM, T=0.6 MM | In distribution | |
| 01-284-10-09 | 11.0 MM STEP, T=1.0 MM | In distribution | |
| 25-401-35-09 | 4 X 2 HOLES, 35 MM, T=0.8 MM | In distribution | |
| 01-006-47-09 | 4 HOLE, 19 MM, T=1.0 MM | In distribution | |
| 25-765-06-61 | 1.5 X 6 MM | In distribution | |
| 25-315-90-91 | 6 HOLE, T=0.6 MM | In distribution | |
| 25-676-07-91 | 1.8 X 7 MM | In distribution | |
| 25-872-11-91 | 2.0 X 11 MM | In distribution | |
| 50-301-03-09 | 3.0 MM STEP, T=0.6 MM | In distribution | |
| 25-320-35-09 | 21 HOLE, 19 X 42 MM, T=0.6 MM | In distribution | |
| 25-397-35-09 | 2 X 2 HOLES, 33 MM, T=0.8 MM | In distribution | |
| 01-333-06-09 | 6 HOLE, 21 MM, T=1.0 MM | In distribution | |
| 50-285-05-09 | 5.0 MM STEP, T=1.4 MM | In distribution | |
| 25-873-47-91 | 2.3 X 7 MM | In distribution | |
| 25-672-06-61 | 2.0 X 6 MM | In distribution | |
| 25-395-27-09 | 4 HOLE, 25 MM, T=0.7 MM | In distribution | |
| 25-675-09-09 | 1.5 X 9 MM | 5 | In distribution |
| 25-675-07-91 | 1.5 X 7 MM | In distribution | |
| 01-331-06-09 | 6 HOLE, 33 MM, T=1.0 MM | In distribution | |
| 50-381-04-91 | 2 X 2 HOLES, 24 MM, T=0.6 MM | In distribution | |
| 25-315-85-91 | 3 X 2 HOLES, 20 MM, T=0.6 MM | In distribution | |
| 25-672-04-09 | 2.0 X 4 MM | 5 | In distribution |
| 50-288-00-09 | 0.0 MM STEP, T=1.0 MM | In distribution | |
| 25-306-32-09 | 12 HOLE, T=0.6 MM | In distribution | |
| 25-872-04-61 | 2.0 X 4 MM | In distribution | |
| 25-304-24-09 | 24 HOLE, T=0.4 MM | In distribution | |
| 25-344-08-09 | 8 HOLE, T=0.6 MM | In distribution | |
| 50-286-07-09 | 7.0 MM STEP, T=1.4 MM | In distribution | |
| 25-017-04-09 | 2 X 2 HOLES, 12 MM, T=0.6 MM | In distribution | |
| 25-331-07-09 | 4 X 3 HOLES, 19 MM, T=0.6 MM | In distribution | |
| 50-380-05-91 | 3 X 2 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 01-104-25-09 | 4.0 MM STEP, T=0.6 MM | In distribution | |
| 50-382-05-91 | 3 X 2 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 25-675-17-09 | 1.5 X 17 MM | 5 | In distribution |
| 25-331-70-91 | 3 X 3 HOLES, 18 MM, T=0.6MM | In distribution | |
| 50-403-06-91 | 3 X 3 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 25-006-09-09 | 85 X 55 MM, T=0.6 MM | In distribution | |
| 25-552-04-91 | 4 HOLE, 30 MM, T=1.0 MM | In distribution | |
| 50-396-06-91 | 6 HOLE, 20 MM, T=0.6 MM | In distribution | |
| 50-386-05-91 | 5 HOLE, T=0.6 MM | In distribution | |
| 25-860-07-09 | 2.0 X 7 MM | 5 | In distribution |
| 25-001-13-09 | 83 X 50 MM, T=0.3 MM | In distribution | |
| 50-285-13-09 | 13.0 MM STEP, T=1.4 MM | In distribution | |
| 50-370-08-91 | 8 HOLE, 49 MM, T=0.6 MM | In distribution | |
| 25-306-24-09 | 24 HOLE, T=0.6 MM | In distribution | |
| 25-325-10-91 | 10 HOLE, 38 MM, T=0.6 MM | In distribution | |
| 25-333-27-09 | 6 HOLE, T=0.8 MM | In distribution | |
| 01-381-07-09 | 2 X 2 HOLES, T=0.6 MM | In distribution | |
| 25-875-15-91 | 1.5 X 15 MM | In distribution | |
| 50-414-04-09 | 2 X 2 HOLES, 17 MM, T=0.5 MM | In distribution | |
| 50-303-05-09 | 5.0 MM STEP, T=0.6 MM | In distribution | |
| 25-306-84-09 | 3 X 3 HOLES, 22 MM, T=0.6 MM | In distribution | |
| 50-300-06-91 | 6.0 MM STEP. T=0.6MM | In distribution | |
| 50-303-04-09 | 4.0 MM STEP, T=0.6 MM | In distribution | |
| 50-280-04-09 | 4.0 MM STEP, T=1.0 MM | In distribution | |
| 25-306-90-09 | 3 X 3 HOLES, 28 MM, T=0.6 MM | In distribution | |
| 25-325-08-91 | 8 HOLE, 31 MM, T=0.6 MM | In distribution | |
| 50-304-10-09 | 10.0 MM STEP, T=0.8 MM | In distribution | |
| 50-404-06-91 | 3 X 3 HOLES, 30 MM, T=0.6 MM | In distribution | |
| 25-570-06-91 | 6 HOLE, 26 MM, T=1.0 MM | In distribution | |
| 99-587-95-04 | 17 HOLE, 26 X 33 MM, T=0.6 MM | In distribution | |
| 01-552-09-09 | 4 HOLE, 39 MM, T=1.0 MM | In distribution | |
| 25-310-22-09 | 6 X 2 HOLES, 27 MM, T=1.0 MM | In distribution | |
| 01-280-07-09 | 7.0 MM STEP, T=0.6 MM | In distribution | |
| 995-5659-01 | 5 X 3 HOLES, 28 MM, T=1.0 MM | In distribution | |
| 01-400-10-09 | 45 X 45 MM, T=0.3 MM | In distribution | |
| 25-875-08-09 | 1.5 X 8 MM | 5 | In distribution |
| 01-282-07-09 | 7.0 MM STEP, T=0.6 MM | In distribution | |
| 25-397-27-09 | 2 X 2 HOLES, 25 MM, T=0.8 MM | In distribution | |
| 50-405-12-09 | 12 HOLE, T=0.7 MM | In distribution | |
| 25-858-05-61 | 1.5 X 5 MM | In distribution | |
| 25-332-04-09 | 4 HOLE, T=0.6 MM | In distribution | |
| 01-383-05-09 | 3 X 2 HOLES, 23 MM, T=1.0 MM | In distribution | |
| 25-308-22-09 | 6 X 2 HOLES, 26 MM, T=0.8 MM | In distribution | |
| 25-766-05-91 | 1.8 X 5 MM | In distribution | |
| 25-560-06-91 | 6 HOLE, T=1.0 MM | In distribution | |
| 25-860-05-61 | 2.0 X 5 MM | In distribution | |
| 25-672-05-09 | 2.0 X 5 MM | 5 | In distribution |
| 25-550-16-91 | 16 HOLE, 100 MM, T=1.0 MM | In distribution | |
| 25-859-05-09 | 1.8 X 5 MM | 5 | In distribution |
| 01-270-03-09 | 3 X 3 HOLES, 20 MM, T=1.0 MM | In distribution | |
| 25-675-08-09 | 1.5 X 8 MM | 5 | In distribution |
| 50-322-04-09 | 4 HOLE, 30 MM, T=1.0 MM | In distribution | |
| 25-662-17-91 | 2.0 X 17 MM | In distribution | |
| 50-284-11-09 | 11.0 MM STEP, T=1.4 MM | In distribution | |
| 25-672-13-91 | 2.0 X 13 MM | In distribution | |
| 50-282-03-09 | 3.0 MM STEP, T=1.0 MM | In distribution | |
| 25-872-19-09 | 2.0 X 19 MM | 5 | In distribution |
| 25-765-09-09 | 1.5 X 9 MM | 5 | In distribution |
| 25-662-15-91 | 2.0 X 15 MM | In distribution | |
| 25-675-15-91 | 1.5 X 15 MM | In distribution | |
| 50-286-15-09 | 15.0 MM STEP, T=1.4 MM | In distribution | |
| 25-326-55-91 | 4 HOLE, T=0.6 MM | In distribution | |
| 25-308-87-09 | 3 X 3 HOLES, 26 MM, T=0.8 MM | In distribution | |
| 01-335-06-09 | 6 HOLE, 27 MM, T=1.0 MM | In distribution | |
| 25-045-35-09 | 41 X 34 MM, T=0.5 MM | In distribution | |
| 25-875-05-61 | 1.5 X 5 MM | In distribution | |
| 25-672-15-09 | 2.0 X 15 MM | 5 | In distribution |
| 25-672-09-91 | 2.0 X 9 MM | In distribution | |
| 50-305-20-09 | 0.0 MM STEP, T=0.8 MM | In distribution | |
| 25-304-17-09 | 7 HOLE, T=0.4 MM | In distribution | |
| 25-336-11-91 | 4 HOLE, 14 MM, T=0.6 MM | In distribution | |
| 25-675-07-09 | 1.5 X 7 MM | 5 | In distribution |
| 25-858-04-91 | 1.5 X 4 MM | In distribution | |
| 25-875-04-61 | 1.5 X 4 MM | In distribution | |
| 25-740-04-09 | 2 X 2 HOLES, 29 MM, T=1.0 MM | In distribution | |
| 50-743-04-09 | 4 HOLE, 11 MM, T=1.0 MM | In distribution | |
| 50-405-09-09 | 5 X 4 HOLES, 33 MM, T=0.7 MM | In distribution | |
| 50-414-06-09 | 6 HOLE, 11 MM, T=1.0 MM | In distribution | |
| 01-006-46-09 | 4 HOLE, 15 MM, T=1.0 MM | In distribution | |
| 25-006-02-09 | 14 X 2 HOLES, 87 MM, T=0.6 MM | In distribution | |
| 50-287-07-09 | 7.0 MM STEP, T=1.0 MM | In distribution | |
| 25-768-06-09 | 1.5 X 6 MM | 5 | In distribution |
| 25-561-05-91 | 5 HOLE, T=1.0 MM | In distribution | |
| 25-673-47-09 | 2.3 X 7 MM | 5 | In distribution |
| 25-870-05-61 | 1.2 X 5 MM | In distribution | |
| 25-308-18-09 | 8 HOLE, 27 MM, T=0.8 MM | In distribution | |
| 25-675-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 25-304-55-91 | 4 HOLE, 17 MM, T=0.6 MM | In distribution | |
| 01-371-07-09 | 2 X 2 HOLES, 15 MM, T=1.0 MM | In distribution | |
| 25-395-31-09 | 4 HOLE, 29 MM, T=0.7 MM | In distribution | |
| 25-330-85-91 | 3 X 3 HOLES, 21 MM, T=0.6 MM | In distribution | |
| 25-675-03-91 | 1.5 X 3.5 MM | In distribution | |
| 25-875-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 25-861-07-61 | 2.3 X 7 MM | In distribution | |
| 01-305-06-09 | 6 HOLE, 32 MM, T=1.0 MM | In distribution | |
| 25-675-03-09 | 1.5 X 3.5 MM | 5 | In distribution |
| 01-200-37-09 | 6 HOLE, 28 MM, T=1.0 MM | In distribution | |
| 25-002-02-09 | 11 X 2 HOLES, 43 MM, T=0.6 MM | In distribution | |
| 25-660-04-91 | 1.0 X 4 MM | In distribution | |
| 50-330-10-09 | 4 X 2 HOLES, 27 MM, T=1.0 MM | In distribution | |
| 25-875-15-09 | 1.5 X 15 MM | 5 | In distribution |
| 01-200-38-09 | 6 HOLE, 33 MM, T=1.0 MM | In distribution | |
| 25-766-04-61 | 1.8 X 4 MM | In distribution | |
| 01-270-00-09 | 4 X 3 HOLES, 21 MM, T=1.0 MM | In distribution | |
| 50-300-04-91 | 4.0 MM STEP, T=0.6MM | In distribution | |
| 25-765-03-91 | 1.5 X 3.5 MM | In distribution | |
| 25-875-13-91 | 1.5 X 13 MM | In distribution | |
| 25-875-07-91 | 1.5 X 7 MM | In distribution | |
| 25-741-14-09 | 2 X 2 HOLES, 34 MM, T=1.0 MM | In distribution | |
| 25-873-49-91 | 2.3 X 9 MM | In distribution | |
| 50-407-09-09 | 5 X 4 HOLES, 33 MM, T=0.7 MM | In distribution | |
| 25-308-28-09 | 8 X 2 HOLES, 36 MM, T=0.8 MM | In distribution | |
| 25-043-01-09 | 40 X 31 MM, T=0.3 MM | In distribution | |
| 25-870-03-61 | 1.2 X 3 MM | In distribution | |
| 25-306-50-09 | 2 X 2 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-306-44-09 | 2 X 2 HOLES, 17 MM, T=0.6 MM | In distribution | |
| 25-022-28-09 | 14 X 2 HOLES, 87 MM, T=1.0 MM | In distribution | |
| 50-330-06-09 | 6 HOLE, 29 MM, T=1.0 MM | In distribution | |
| 25-859-05-91 | 1.8 X 5 MM | In distribution | |
| 01-330-06-09 | 6 HOLE, 29 MM, T=1.0 MM | In distribution | |
| 25-340-11-09 | 11 HOLE, T=0.6 MM | In distribution | |
| 50-305-04-09 | 4.0 MM STEP, T=0.8 MM | In distribution | |
| 25-871-07-61 | 1.4 X 7 MM | In distribution | |
| 25-765-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 01-006-21-09 | 6.0 MM STEP, T=0.7 MM | In distribution | |
| 50-280-07-09 | 7.0 MM STEP, T=1.0 MM | In distribution | |
| 25-045-41-09 | 40 X 35 MM, T=0.5 MM | In distribution | |
| 25-662-15-09 | 2.0 X 15 MM | 5 | In distribution |
| 25-578-06-91 | 3 X 3 HOLES, 30 MM, T=1.0 MM | In distribution | |
| 25-672-17-91 | 2.0 X 17 MM | In distribution | |
| 25-675-11-91 | 1.5 X 11 MM | In distribution | |
| 00-101-56-09 | 2 X 2 HOLES, 20 MM, T=0.5 MM | In distribution | |
| 01-007-46-09 | 4 HOLE, 15 MM, T=1.0 MM | In distribution | |
| 50-303-06-09 | 6.0 MM STEP, T=0.6 MM | In distribution | |
| 50-305-28-09 | 8.0 MM STEP, T=1.0 MM | In distribution | |
| 25-338-12-09 | 12 HOLE, T=0.6 MM | In distribution | |
| 50-304-04-09 | 4.0 MM STEP, T=0.8 MM | In distribution | |
| 50-305-10-09 | 10.0 MM STEP, T=1.0 MM | In distribution | |
| 25-740-24-09 | 2 X 2 HOLES, 39 MM, T=1.0 MM | In distribution | |
| 25-304-04-09 | 4 HOLE, T=0.4 MM | In distribution | |
| 25-396-39-09 | 4 HOLE, T=1.0 MM | In distribution | |
| 25-662-09-91 | 2.0 X 9 MM | In distribution | |
| 25-673-45-91 | 2.3 X 5 MM | In distribution | |
| 99-586-30-01 | 4 HOLE, T=0.4 MM | In distribution | |
| 25-871-04-61 | 1.4 X 4 MM | In distribution | |
| 25-304-14-09 | 4 HOLE, T=0.4 MM | In distribution | |
| 01-007-47-09 | 4 HOLE, 19 MM, T=1.0 MM | In distribution | |
| 25-872-17-91 | 2.0 X 17 MM | In distribution | |
| 25-675-08-91 | 1.5 X 8 MM | In distribution | |
| 50-286-11-09 | 11.0 MM STEP, T=1.4 MM | In distribution | |
| 25-875-09-09 | 1.5 X 9 MM | 5 | In distribution |
| 25-308-90-09 | 3 X 3 HOLES, 29 MM, T=0.8 MM | In distribution | |
| 25-197-17-09 | 7 HOLE, 102 MM, T=0.5 MM | In distribution | |
| 25-578-11-09 | 3 X 3 HOLES, 28 MM, T=0.8 MM | In distribution | |
| 99-576-69-01 | 7 HOLE, 19 MM, T=0.5 MM | In distribution | |
| 995-6458-02-91 | 1.5 X 5 MM | In distribution | |
| 25-308-16-09 | 6 HOLE, 18 MM, T=0.8 MM | In distribution | |
| 25-308-50-09 | 2 X 2 HOLES, 23 MM, T=0.8 MM | In distribution | |
| 25-875-03-91 | 1.5 X 3.5 MM | In distribution | |
| 25-334-08-09 | 5 X 3 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-338-05-09 | 5 HOLE, T=0.6 MM | In distribution | |
| 25-858-07-61 | 1.5 X 7 MM | In distribution | |
| 25-660-02-61 | 1.0 X 2 MM | In distribution | |
| 50-284-13-09 | 13.0 MM STEP, T=1.4 MM | In distribution | |
| 25-285-10-91 | 4 HOLE, T=1.0 MM | In distribution | |
| 25-765-15-91 | 1.5 X 15 MM | In distribution | |
| 50-286-13-09 | 13.0 MM STEP, T=1.4 MM | In distribution | |
| 25-042-20-09 | 34 X 32 MM, T=0.2 MM | In distribution | |
| 25-675-11-09 | 1.5 X 11 MM | 5 | In distribution |
| 25-673-49-09 | 2.3 X 9 MM | 5 | In distribution |
| 25-398-31-09 | 4 HOLE, 29 MM, T=0.8 MM | In distribution | |
| 50-406-02-09 | 7 HOLE, T=0.6 MM | In distribution | |
| 25-676-05-09 | 1.8 X 5 MM | 5 | In distribution |
| 25-872-09-09 | 2.0 X 9 MM | 5 | In distribution |
| 25-870-06-61 | 1.2 X 6 MM | In distribution | |
| 25-873-49-09 | 2.3 X 9 MM | 5 | In distribution |
| 25-396-26-09 | 4 HOLE, 24 MM, T=0.7 MM | In distribution | |
| 25-872-04-91 | 2.0 X 4 MM | In distribution | |
| 50-403-02-09 | 7 HOLE, T=1.0 MM | In distribution | |
| 25-858-04-09 | 1.5 X 4 MM | 5 | In distribution |
| 01-309-04-09 | 4 HOLE, 17 MM, T=1.0 MM | In distribution | |
| 25-672-07-91 | 2.0 X 7 MM | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plate, Bone | Stryker Leibinger Gmbh & Co. KG | 1,338 |
| 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 |
| Level ONE Neuro | KLS-Martin L.P. | 253 |
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.