Level ONE CMF, Sterile
Plate, Mini, Tlts, Subcondylar, K SHP W/TAB, Right, 2.0-2.5 MM Screw, CP Titanium
3manufacturers in China registered for this device type
416catalogue 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 | 2026-03-23 |
| Record revised | 2026-07-15 (version 10) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 25-887-11-74 | 2.7 X 11 MM | 4 | In distribution |
| 25-873-19-71 | 2.3 X 19 MM | In distribution | |
| 25-661-05-74 | 1.2 X 5 MM | 4 | In distribution |
| 25-320-28-71 | 9 HOLE, 22 X 24 MM, T=0.6 MM | In distribution | |
| 25-883-09-71 | 2.3 X 9 MM | In distribution | |
| 25-882-05-74 | 2.0 X 5 MM | 4 | In distribution |
| 25-883-13-74 | 2.3 X 13 MM | 4 | In distribution |
| 25-330-26-71 | 34 HOLE, T=0.6 MM | In distribution | |
| 25-306-55-71 | 6 HOLE, 25 MM, T=0.6 MM | In distribution | |
| 25-308-04-71 | 4 HOLE, 18 MM, T=0.8 MM | In distribution | |
| 25-306-04-71 | 4 HOLE, T=0.6 MM | In distribution | |
| 50-746-22-71 | 22 HOLE, 161 MM, T=2.8 MM | In distribution | |
| 50-760-26-71 | 26 HOLE, 190 MM, T=2.5 MM | In distribution | |
| 25-332-08-71 | 8 HOLE, T=0.6 MM | In distribution | |
| 25-768-06-78 | 1.5 X 6 MM | 8 | In distribution |
| 25-870-09-71 | 1.2 X 9 MM | In distribution | |
| 25-872-17-71 | 2.0 X 17 MM | In distribution | |
| 50-760-12-71 | 12 HOLE, 94 MM, T=2.5 MM | In distribution | |
| 25-871-05-71 | 1.4 X 5 MM | In distribution | |
| 25-875-04-71 | 1.5 X 4 MM | In distribution | |
| 25-311-85-71 | 2 X 2 HOLES, 16 MM, T=0.6 MM | In distribution | |
| 25-875-11-71 | 1.5 X 11 MM | In distribution | |
| 25-342-06-71 | 6 HOLE, T=0.6 MM | In distribution | |
| 50-799-36-71 | 36 HOLE, 258 MM, T=3.0 MM | In distribution | |
| 25-765-13-71 | 1.5 X 13 MM | In distribution | |
| 25-882-13-71 | 2.0 X 13 MM | In distribution | |
| 25-310-09-71 | 6 X 4 HOLES, 33 MM, T=1.0 MM | In distribution | |
| 50-379-04-71 | 2 X 2 HOLES, 24 MM, T=0.6 MM | In distribution | |
| 25-871-07-71 | 1.4 X 7 MM | In distribution | |
| 25-872-05-78 | 2.0 X 5 MM | 8 | In distribution |
| 50-794-33-71 | 32 HOLE, 227 MM, T=2.8 MM | In distribution | |
| 25-768-06-74 | 1.5 X 6 MM | 4 | In distribution |
| 50-794-35-71 | 36 HOLE, 259 MM, T=2.8 MM | In distribution | |
| 25-333-05-71 | 3 X 2 HOLES, 15 MM, T=0.6 MM | In distribution | |
| 25-042-15-71 | 30 X 30 MM, T=0.3 MM | In distribution | |
| 25-766-07-71 | 1.8 X 7 MM | In distribution | |
| 25-765-03-78 | 1.5 X 3.5 MM | 8 | In distribution |
| 25-872-19-71 | 2.0 X 19 MM | In distribution | |
| 01-200-38-71 | 6 HOLE, 33 MM, T=1.0 MM | In distribution | |
| 25-889-13-71 | 3.1 X 13 MM | In distribution | |
| 25-874-07-71 | 2.5 X 7 MM | In distribution | |
| 25-875-43-71 | 1.5 X 3.5 MM | In distribution | |
| 50-794-20-71 | 20 HOLE, 160 MM, T=3.0 MM | In distribution | |
| 25-870-04-74 | 1.2 X 4 MM | 4 | In distribution |
| 25-304-14-71 | 4 HOLE, T=0.4 MM | In distribution | |
| 50-794-34-71 | 34 HOLE, 243 MM, T=2.8 MM | In distribution | |
| 25-304-23-71 | 2 X 2 HOLES, 12 MM, T=0.4 MM | In distribution | |
| 25-660-03-74 | 1.0 X 3 MM | 4 | In distribution |
| 25-885-05-74 | 2.5 X 5 MM | 4 | In distribution |
| 25-010-06-71 | 3 X 2 HOLES, 19 MM, T=0.6 MM | In distribution | |
| 25-308-17-71 | 7 HOLE, 29 MM, T=0.8 MM | In distribution | |
| 25-765-04-71 | 1.5 X 4 MM | In distribution | |
| 25-882-15-74 | 2.0 X 15 MM | 4 | In distribution |
| 25-878-05-78 | 1.5 X 5 MM | 8 | In distribution |
| 25-043-17-71 | 45 X 45 MM, T=0.3 MM | In distribution | |
| 25-660-06-71 | 1.0 X 6 MM | In distribution | |
| 25-873-05-71 | 2.3 X 5 MM | In distribution | |
| 25-765-04-74 | 1.5 X 4 MM | 4 | In distribution |
| 25-396-39-71 | 4 HOLE, T=1.0 MM | In distribution | |
| 25-198-08-75 | 2.0 X 8 MM THD, TTL=10 MM | 5 | In distribution |
| 25-876-05-71 | 1.8 X 5 MM | In distribution | |
| 50-330-08-71 | 4 X 2 HOLES, 21 MM, T=1.0 MM | In distribution | |
| 25-306-16-71 | 6 HOLE, T=0.6 MM | In distribution | |
| 25-870-11-71 | 1.2 X 11 MM | In distribution | |
| 25-332-04-71 | 4 HOLE, T=0.6 MM | In distribution | |
| 25-765-09-71 | 1.5 X 9 MM | In distribution | |
| 50-791-26-71 | 26 HOLE, 184 MM, T=3.0 MM | In distribution | |
| 25-310-85-71 | 2 X 2 HOLES, 16 MM, T=0.6 MM | In distribution | |
| 25-889-11-71 | 3.1 X 11 MM | In distribution | |
| 25-334-05-71 | 3 X 2 HOLES, 15 MM, T=0.6 MM | In distribution | |
| 50-303-09-71 | 9.0 MM STEP, T=0.6 MM | In distribution | |
| 50-174-01-71 | In distribution | ||
| 25-765-03-74 | 1.5 X 3.5 MM | 4 | In distribution |
| 50-779-32-71 | 32 HOLE, 222 MM, T=2.0 MM | In distribution | |
| 25-882-17-71 | 2.0 X 17 MM | In distribution | |
| 25-882-09-71 | 2.0 X 9 MM | In distribution | |
| 25-768-06-71 | 1.5 X 6 MM | In distribution | |
| 25-872-13-71 | 2.0 X 13 MM | In distribution | |
| 25-765-03-71 | 1.5 X 3.5 MM | In distribution | |
| 25-883-05-71 | 2.3 X 5 MM | In distribution | |
| 50-771-26-71 | 26 HOLE, 182 MM, T=2.0 MM | In distribution | |
| 50-302-01-71 | 1.0 MM STEP, T=0.6MM | In distribution | |
| 25-874-06-71 | 2.5 X 6 MM | In distribution | |
| 50-747-24-71 | 24 HOLE, 176 MM, T=2.8 MM | In distribution | |
| 25-320-23-71 | 6 HOLE, 9 X 41 MM, T=1.0 MM | In distribution | |
| 25-045-41-71 | 40 X 35 MM, T=0.5 MM | In distribution | |
| 25-885-09-71 | 2.5 X 9 MM | In distribution | |
| 25-660-04-71 | 1.0 X 4 MM | In distribution | |
| 25-878-06-78 | 1.5 X 6 MM | 8 | In distribution |
| 50-799-32-71 | 32 HOLE, 227 MM, T=3.0 MM | In distribution | |
| 25-198-06-70 | 2.0 X 6 MM THD, TTL=8 MM | 10 | In distribution |
| 50-381-05-71 | 3 X 2 HOLES, 23 MM, T=0.7 MM | In distribution | |
| 25-320-25-71 | 9 HOLE, 31 X 26 MM, T=1.0 MM | In distribution | |
| 25-306-00-71 | 6 HOLE, 23 MM, T=0.6 MM | In distribution | |
| 25-044-35-71 | 40 X 35 MM, T=0.4 MM | In distribution | |
| 50-773-26-71 | 26 HOLE, 182 MM, T=2.0 MM | In distribution | |
| 25-331-04-71 | 4 HOLE, T=0.6 MM | In distribution | |
| 25-044-22-71 | 37 X 30 MM, T=0.4 MM | In distribution | |
| 25-306-14-71 | 4 HOLE, T=0.6 MM | In distribution | |
| 50-381-04-71 | 2 X 2 HOLES, 24 MM, T=0.6 MM | In distribution | |
| 25-044-23-71 | 37 X 30 MM, T=0.4 MM | In distribution | |
| 25-310-06-71 | 6 HOLE, 28 MM, T=1.0 MM | In distribution | |
| 25-198-08-71 | 2.0 X 8 MM THD, TTL=10 MM | In distribution | |
| 50-760-32-71 | 32 HOLE, 222 MM, T=2.5 MM | In distribution | |
| 25-043-03-71 | T=0.3 MM | In distribution | |
| 25-887-09-71 | 2.7 X 9 MM | In distribution | |
| 25-872-07-78 | 2.0 X 7 MM | 8 | In distribution |
| 25-306-22-71 | 6 X 2 HOLES, 26 MM, T=0.6 MM | In distribution | |
| 25-660-05-74 | 1.0 X 5 MM | 4 | In distribution |
| 25-882-11-71 | 2.0 X 11 MM | In distribution | |
| 25-768-07-78 | 1.5 X 7 MM | 8 | In distribution |
| 25-878-07-71 | 1.5 X 7 MM | In distribution | |
| 25-872-07-74 | 2.0 X 7 MM | 4 | In distribution |
| 25-875-09-71 | 1.5 X 9 MM | In distribution | |
| 25-765-04-78 | 1.5 X 4 MM | 8 | In distribution |
| 25-879-07-78 | 2.0 X 7 MM | 8 | In distribution |
| 50-793-26-71 | 26 HOLE, 184 MM, T=3.0 MM | In distribution | |
| 25-885-13-71 | 2.5 X 13 MM | In distribution | |
| 25-661-07-71 | 1.2 X 7 MM | In distribution | |
| 25-872-06-74 | 2.0 X 6 MM | 4 | In distribution |
| 25-875-05-74 | 1.5 X 5 MM | 4 | In distribution |
| 25-887-05-71 | 2.7 X 5 MM | In distribution | |
| 50-747-22-71 | 22 HOLE, 161 MM, T=2.8 MM | In distribution | |
| 50-779-36-71 | 36 HOLE, 254 MM, T=2.0 MM | In distribution | |
| 25-768-04-78 | 1.5 X 4 MM | 8 | In distribution |
| 50-377-04-71 | 2 X 2 HOLES, 20 MM, T=0.6 MM | In distribution | |
| 25-401-40-71 | 4 X 2 HOLES, 40 MM, T=0.8 MM | In distribution | |
| 25-874-13-71 | 2.5 X 13 MM | In distribution | |
| 25-870-11-74 | 1.2 X 11 MM | 4 | In distribution |
| 50-405-07-71 | 4 X 3 HOLES, 28 MM, T=0.7 MM | In distribution | |
| 50-775-26-71 | 26 HOLE, 190 MM, T=2.0 MM | In distribution | |
| 25-873-07-71 | 2.3 X 7 MM | In distribution | |
| 25-874-17-71 | 2.5 X 17 MM | In distribution | |
| 25-765-05-74 | 1.5 X 5 MM | 4 | In distribution |
| 25-660-04-74 | 1.0 X 4 MM | 4 | In distribution |
| 25-396-56-71 | 6 HOLE, T=1.0 MM | In distribution | |
| 25-875-43-74 | 1.5 X 3.5 MM | 4 | In distribution |
| 25-877-03-71 | 1.2 X 3 MM | In distribution | |
| 25-882-05-71 | 2.0 X 5 MM | In distribution | |
| 25-878-06-71 | 1.5 X 6 MM | In distribution | |
| 25-765-09-78 | 1.5 X 9 MM | 8 | In distribution |
| 25-310-17-71 | 7 HOLE, 29 MM, T=1.0 MM | In distribution | |
| 25-878-05-71 | 1.5 X 5 MM | In distribution | |
| 25-878-04-71 | 1.5 X 4 MM | In distribution | |
| 25-878-07-74 | 1.5 X 7 MM | 4 | In distribution |
| 50-712-04-71 | 4 HOLE, 28 MM, T=1.5 MM | In distribution | |
| 25-870-04-71 | 1.2 X 4 MM | In distribution | |
| 25-306-17-71 | 7 HOLE, T=0.6 MM | In distribution | |
| 25-870-07-74 | 1.2 X 7 MM | 4 | In distribution |
| 25-308-22-71 | 6 X 2 HOLES, 26 MM, T=0.8 MM | In distribution | |
| 25-310-70-71 | 2 X 2 HOLES, 14 MM, T=0.6 MM | In distribution | |
| 25-304-32-71 | 12 HOLE, T=0.4 MM | In distribution | |
| 25-043-04-71 | 47 X 37 MM, T=0.3 MM | In distribution | |
| 25-873-15-71 | 2.3 X 15 MM | In distribution | |
| 25-887-07-74 | 2.7 X 7 MM | 4 | In distribution |
| 25-306-07-71 | 4 X 3 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-882-07-74 | 2.0 X 7 MM | 4 | In distribution |
| 50-375-04-71 | 2 X 2 HOLES, 20 MM, T=0.6 MM | In distribution | |
| 25-311-70-71 | 2 X 2 HOLES, 14 MM, T=0.6 MM | In distribution | |
| 25-331-24-71 | 24 HOLE, T=0.6 MM | In distribution | |
| 25-344-07-71 | 7 HOLE, T=0.6 MM | In distribution | |
| 50-302-03-71 | 3.0 MM STEP, T=0.6MM | In distribution | |
| 50-760-36-71 | 36 HOLE, 254 MM, T=2.5 MM | In distribution | |
| 25-043-10-71 | 67 X 24 MM, T=0.3 MM | In distribution | |
| 25-870-09-74 | 1.2 X 9 MM | 4 | In distribution |
| 25-042-16-71 | 37 X 35 MM, T=0.3 MM | In distribution | |
| 25-765-15-74 | 1.5 X 15 MM | 4 | In distribution |
| 25-310-24-71 | 24 HOLE, 108 MM, T=1.0 MM | In distribution | |
| 25-310-22-71 | 6 X 2 HOLES, 27 MM, T=1.0 MM | In distribution | |
| 50-302-07-71 | 7.0 MM STEP, T=0.6MM | In distribution | |
| 25-879-05-78 | 2.0 X 5 MM | 8 | In distribution |
| 25-310-16-71 | 6 HOLE, 19 MM, T=1.0 MM | In distribution | |
| 25-765-11-74 | 1.5 X 11 MM | 4 | In distribution |
| 25-875-13-71 | 1.5 X 13 MM | In distribution | |
| 25-320-35-71 | 21 HOLE, 19 X 42 MM, T=0.6 MM | In distribution | |
| 25-043-07-71 | 45 X 45 MM, T=0.3 MM | In distribution | |
| 25-877-06-71 | 1.2 X 6 MM | In distribution | |
| 50-760-20-71 | 20 HOLE, 159 MM, T=2.5 MM | In distribution | |
| 25-887-13-74 | 2.7 X 13 MM | 4 | In distribution |
| 25-882-15-71 | 2.0 X 15 MM | In distribution | |
| 25-872-15-71 | 2.0 X 15 MM | In distribution | |
| 25-768-04-71 | 1.5 X 4 MM | In distribution | |
| 25-552-04-71 | 4 HOLE, 30 MM, T=1.0 MM | In distribution | |
| 25-875-05-71 | 1.5 X 5 MM | In distribution | |
| 25-883-07-74 | 2.3 X 7 MM | 4 | In distribution |
| 25-875-11-74 | 1.5 X 11 MM | 4 | In distribution |
| 50-302-05-71 | 5.0 MM STEP, T=0.6MM | In distribution | |
| 50-332-06-71 | 6 HOLE, 35 MM, T=1.0 MM | In distribution | |
| 25-044-32-71 | 36 X 32 MM, T=0.4 MM | In distribution | |
| 25-875-04-74 | 1.5 X 4 MM | 4 | In distribution |
| 25-197-09-71 | 9 HOLE, 130 MM, T=0.5 MM | In distribution | |
| 25-308-14-71 | 4 HOLE, T=0.8 MM | In distribution | |
| 25-870-05-74 | 1.2 X 5 MM | 4 | In distribution |
| 25-044-34-71 | 40 X 35 MM, T=0.4 MM | In distribution | |
| 25-873-11-71 | 2.3 X 11 MM | In distribution | |
| 25-044-01-71 | 37 X 30 MM, T=0.3 MM | In distribution | |
| 50-331-06-71 | 6 HOLE, 33 MM, T=1.0 MM | In distribution | |
| 25-306-06-71 | 6 HOLE, T=0.6 MM | In distribution | |
| 25-304-16-71 | 6 HOLE, T=0.4 MM | In distribution | |
| 25-320-24-71 | 9 HOLE, 31 X 26 MM, T=1.0 MM | In distribution | |
| 25-320-34-71 | 21 HOLE, 19 X 42 MM, T=0.6 MM | In distribution | |
| 50-730-06-71 | 6 HOLE, 29 MM, T=1.0 MM | In distribution | |
| 25-875-09-74 | 1.5 X 9 MM | 4 | In distribution |
| 25-043-01-71 | 40 X 31 MM, T=0.3 MM | In distribution | |
| 25-661-05-71 | 1.2 X 5 MM | In distribution | |
| 25-334-08-71 | 5 X 3 HOLES, 23 MM, T=0.6 MM | In distribution | |
| 25-198-08-70 | 2.0 X 8 MM THD, TTL=10 MM | 10 | In distribution |
| 25-872-06-71 | 2.0 X 6 MM | In distribution | |
| 50-766-06-71 | 6 HOLE, 43 MM, T=2.0 MM | In distribution | |
| 25-766-05-71 | 1.8 X 5 MM | In distribution | |
| 25-310-04-71 | 4 HOLE, 18 MM, T=1.0 MM | In distribution | |
| 25-304-24-71 | 24 HOLE, T=0.4 MM | In distribution | |
| 25-304-17-71 | 7 HOLE, T=0.4 MM | In distribution | |
| 25-882-19-71 | 2.0 X 19 MM | In distribution | |
| 25-873-07-74 | 2.3 X 7 MM | 4 | In distribution |
| 25-396-44-71 | 4 HOLE, T=1.0 MM | In distribution | |
| 25-768-05-74 | 1.5 X 5 MM | 4 | In distribution |
| 25-873-05-74 | 2.3 X 5 MM | 4 | In distribution |
| 25-870-03-74 | 1.2 X 3 MM | 4 | In distribution |
| 25-320-29-71 | 9 HOLE, 22 X 24 MM, T=0.6 MM | In distribution | |
| 25-306-18-71 | 8 HOLE, T=0.6 MM | In distribution | |
| 25-661-03-71 | 1.2 X 3 MM | In distribution | |
| 50-174-04-75 | 2.7 MM HEAD | 5 | In distribution |
| 25-887-17-71 | 2.7 X 17 MM | In distribution | |
| 25-306-32-71 | 12 HOLE, T=0.6 MM | In distribution | |
| 25-883-05-74 | 2.3 X 5 MM | 4 | In distribution |
| 25-308-09-71 | 6 X 4 HOLES, 33 MM, T=0.8 MM | In distribution | |
| 25-873-09-74 | 2.3 X 9 MM | 4 | In distribution |
| 25-288-08-71 | 8 HOLE, T=1.0 MM | In distribution | |
| 25-870-13-74 | 1.2 X 13 MM | 4 | In distribution |
| 25-878-06-74 | 1.5 X 6 MM | 4 | In distribution |
| 25-873-13-71 | 2.3 X 13 MM | In distribution | |
| 25-304-06-71 | 6 HOLE, T=0.4 MM | In distribution | |
| 50-407-07-71 | 4 X 3 HOLES, 28 MM, T=0.7 MM | In distribution | |
| 25-874-09-71 | 2.5 X 9 MM | In distribution | |
| 25-320-32-71 | 7 HOLE, 19 X 12 MM, T=0.6 MM | In distribution | |
| 50-714-04-71 | 4 HOLE, 33 MM, T=1.5 MM | In distribution | |
| 25-043-06-71 | 45 X 45 MM, T=0.2 MM | In distribution | |
| 25-308-06-71 | 6 HOLE, 28 MM, T=0.8 MM | In distribution | |
| 25-765-06-78 | 1.5 X 6 MM | 8 | In distribution |
| 25-765-11-71 | 1.5 X 11 MM | In distribution | |
| 25-882-13-74 | 2.0 X 13 MM | 4 | In distribution |
| 25-870-06-74 | 1.2 X 6 MM | 4 | In distribution |
| 25-661-07-74 | 1.2 X 7 MM | 4 | In distribution |
| 50-321-04-71 | 4 HOLE, 26 MM, T=1.0 MM | In distribution | |
| 01-100-36-71 | 6 HOLE, 25 MM, T=1.0 MM | In distribution | |
| 25-765-07-78 | 1.5 X 7 MM | 8 | In distribution |
| 25-044-02-71 | 37 X 28 MM, T=0.4 MM | In distribution | |
| 25-304-04-71 | 4 HOLE, T=0.4 MM | In distribution | |
| 25-876-04-71 | 1.8 X 4 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 |
| 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 |
| 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.