Bioplate®
Straight Plate - Low-Profile - 2 hole - 14 mm (3), Self-Drilling Screw - 4 mm (6) [5 PK]
3manufacturers in China registered for this device type
669catalogue numbers in this listing
16510(k) clearances naming this product code
2recalls on this 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 | Bioplate, Inc., United States |
|---|---|
| FDA product code | JEY |
| Device type | Plate, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4760 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K002426 |
| Record published | 2015-10-22 |
| Record revised | 2024-06-19 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5, pack of 10 |
| Sizes | Length 3 to 200 mm; length 20 cm; length 45 m |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 81-2001 | Length 19 mm | In distribution | |
| 81-3138[US] | Length 15 mm | In distribution | |
| P2YP-06-18 | Length 18 mm | In distribution | |
| 81-2007-CP | Length 10 mm | In distribution | |
| P2YB-05-18 | Length 18 mm | In distribution | |
| SCE8-12-05 | Length 12 mm | 5 | In distribution |
| SCE4-13-01 | Length 13 mm | In distribution | |
| 81-3583 | In distribution | ||
| SCE2-12-01 | Length 12 mm | In distribution | |
| SCR4-07-05[US] | Length 7 mm | 5 | In distribution |
| 81-2069 | Length 4 mm | In distribution | |
| 81-5744[US] | Length 4 mm | In distribution | |
| SCR4-06-05[US] | Length 6 mm | 5 | In distribution |
| 81-3580[US] | In distribution | ||
| 81-2000 | Length 11 mm | 5 | In distribution |
| 81-5785[US] | Length 99 mm | In distribution | |
| 81-3354 | Length 18 mm | In distribution | |
| 81-5742 | Length 5 mm | 5 | In distribution |
| SCP4-14-05 | Length 12 mm | 5 | In distribution |
| SCR8-08-01 | Length 8 mm | In distribution | |
| SCE8-05-01 | Length 5 mm | In distribution | |
| SCE2-03-05 | Length 3 mm | 5 | In distribution |
| 81-3018[US] | Length 11 mm | In distribution | |
| 81-2078 | Length 6 mm | 5 | In distribution |
| SCE2-10-05 | Length 10 mm | 5 | In distribution |
| SCR4-15-05[US] | Length 15 mm | 5 | In distribution |
| 81-3060[US] | Length 63 mm | In distribution | |
| 81-3034[US] | Length 11 mm | In distribution | |
| 81-3060 | Length 63 mm | In distribution | |
| SCE4-05-05 | Length 5 mm | 5 | In distribution |
| 81-2010 | Length 44 mm | In distribution | |
| SCE8-04-05 | Length 4 mm | 5 | In distribution |
| 81-3028[US] | Length 20 mm | In distribution | |
| 81-2012[US] | Length 4 mm | 5 | In distribution |
| SCD2-06-05 | Length 6 mm | 5 | In distribution |
| 81-2004[US] | Length 15 mm | In distribution | |
| SCE8-10-01 | Length 10 mm | In distribution | |
| P2YW-06-18[US] | Length 18 mm | In distribution | |
| 81-3159-CP | Length 79 mm | In distribution | |
| SCE4-09-05[US] | Length 9 mm | 5 | In distribution |
| P2ST-04-15 | Length 15 mm | In distribution | |
| P4SK-04-28 | Length 28 mm | In distribution | |
| SCE2-04-01 | Length 4 mm | In distribution | |
| 81-2013 | Length 5 mm | 5 | In distribution |
| P2LL-07-23 | Length 23 mm | In distribution | |
| P2XW-07-17 | Length 17 mm | In distribution | |
| SCR8-04-05[US] | Length 4 mm | 5 | In distribution |
| P2TB-04-16 | Length 16 mm | In distribution | |
| SCR4-06-05 | Length 6 mm | 5 | In distribution |
| 81-2007 | Length 10 mm | In distribution | |
| 81-3041[US] | Length 8 mm | 5 | In distribution |
| 81-2065[US] | Length 3 mm | In distribution | |
| SCD8-03-01 | Length 3 mm | In distribution | |
| 81-3358 | Length 4 mm | 6 | In distribution |
| 81-3027 | Length 12 mm | 5 | In distribution |
| P2ZR-04-16 | Length 16 mm | In distribution | |
| 81-2080[US] | Length 4 mm | 50 | In distribution |
| 81-3035-CP | Length 18 mm | In distribution | |
| 81-2001-CP | Length 19 mm | In distribution | |
| SCR4-09-05 | Length 9 mm | 5 | In distribution |
| SCE2-04-05[US] | Length 4 mm | 5 | In distribution |
| P2TB-05-19 | Length 19 mm | In distribution | |
| SCD2-05-01 | Length 5 mm | In distribution | |
| 81-2000[US] | Length 11 mm | 5 | In distribution |
| SCE2-12-05[US] | Length 12 mm | 5 | In distribution |
| SCR2-06-01 | Length 6 mm | In distribution | |
| SCD8-05-01 | Length 5 mm | In distribution | |
| P4XB-08-39 | Length 39 mm | In distribution | |
| P2RW-04-13 | Length 13 mm | In distribution | |
| P2SB-04-19 | Length 19 mm | In distribution | |
| 81-5746[US] | Length 4 mm | 50 | In distribution |
| P4LR-04-17 | Length 17 mm | In distribution | |
| P4LR-07-40 | Length 40 mm | In distribution | |
| P4ST-16-99[US] | Length 100 mm | In distribution | |
| 81-5785 | Length 99 mm | In distribution | |
| P2TB-04-17 | Length 17 mm | In distribution | |
| P2SW-06-23 | Length 23 mm | In distribution | |
| P2SB-02-14[US] | Length 14 mm | In distribution | |
| SCE4-17-05[US] | Length 17 mm | 5 | In distribution |
| 81-3051 | Length 5 mm | In distribution | |
| SCR2-04-01[US] | Length 4 mm | In distribution | |
| 81-3141[US] | Length 131 mm | In distribution | |
| 81-3031[US] | Length 16 mm | In distribution | |
| SCR8-05-05 | Length 5 mm | 5 | In distribution |
| P2XP-07-17 | Length 17 mm | In distribution | |
| 81-3519 | Length 11 mm | 50 | In distribution |
| SCE8-06-05 | Length 6 mm | 5 | In distribution |
| SCD3-06-01 | Length 6 mm | In distribution | |
| SCD2-04-50 | Length 4 mm | 50 | In distribution |
| P2BX-04-10 | Length 10 mm | In distribution | |
| 81-7322 | In distribution | ||
| 81-5898 | In distribution | ||
| 81-3582 | In distribution | ||
| 81-2079 | Length 4 mm | 50 | In distribution |
| SCR2-04-05[US] | Length 4 mm | 5 | In distribution |
| P2BN-08-24 | Length 24 mm | In distribution | |
| 81-3020 | Length 15 mm | In distribution | |
| P2CP-08-30 | Length 30 mm | In distribution | |
| P1MC-36-43 | Length 43 mm | In distribution | |
| 81-3147 | Length 15 mm | 3 | In distribution |
| SCR4-13-01 | Length 13 mm | In distribution | |
| 81-2069[US] | Length 4 mm | In distribution | |
| P2XW-07-17[US] | Length 17 mm | In distribution | |
| 81-3053 | Length 8 mm | In distribution | |
| 81-3131 | Length 14 mm | In distribution | |
| 81-3578[US] | In distribution | ||
| 81-3050[US] | Length 4 mm | In distribution | |
| SCR8-03-01 | Length 3 mm | In distribution | |
| 81-3144 | Length 14 mm | In distribution | |
| 81-3055 | Length 5 mm | In distribution | |
| 81-3136 | Length 14 mm | In distribution | |
| 81-3306 | Length 15 mm | 50 | In distribution |
| 81-3591[US] | In distribution | ||
| P2NW-06-17 | Length 17 mm | In distribution | |
| 81-3528 | Length 14 mm | 50 | In distribution |
| 81-3144[US] | Length 14 mm | In distribution | |
| P2SB-04-17 | Length 17 mm | In distribution | |
| SCR4-15-01 | Length 15 mm | In distribution | |
| 81-3030-CP | Length 18 mm | In distribution | |
| 81-3054[US] | Length 10 mm | In distribution | |
| 81-3581[US] | In distribution | ||
| 81-3026 | Length 92 mm | In distribution | |
| 81-3148 | Length 15 mm | In distribution | |
| SCD2-04-05[US] | Length 4 mm | 5 | In distribution |
| SCR4-04-05[US] | Length 4 mm | 5 | In distribution |
| 81-2003 | Length 17 mm | In distribution | |
| SCD2-06-01 | Length 6 mm | In distribution | |
| SCP2-12-05 | Length 12 mm | 5 | In distribution |
| 81-3586[US] | In distribution | ||
| SCE8-03-05 | Length 5 mm | 5 | In distribution |
| SCR4-05-05 | Length 5 mm | 5 | In distribution |
| 81-5744 | Length 4 mm | In distribution | |
| P2CP-04-15 | Length 15 mm | In distribution | |
| P2TB-05-15 | Length 15 mm | In distribution | |
| 81-3034-CP | Length 11 mm | 5 | In distribution |
| SCR4-14-05 | Length 14 mm | 5 | In distribution |
| P4XP-06-26 | Length 26 mm | In distribution | |
| 81-3140[US] | Length 134 mm | In distribution | |
| SCD8-04-01 | Length 4 mm | In distribution | |
| 81-3017 | Length 6 mm | In distribution | |
| 81-3021[US] | Length 48 mm | In distribution | |
| 81-5901 | In distribution | ||
| SCE4-11-01 | Length 11 mm | In distribution | |
| 81-5786 | Length 120 mm | In distribution | |
| 81-2070 | Length 5 mm | In distribution | |
| SCE2-06-05 | Length 6 mm | 5 | In distribution |
| SCE4-13-05 | Length 13 mm | 5 | In distribution |
| P4ZL-04-21 | Length 21 mm | In distribution | |
| 81-3040[US] | Length 6 mm | 5 | In distribution |
| 81-3023[US] | Length 90 mm | In distribution | |
| 81-5788[US] | Length 97 mm | In distribution | |
| P2CP-06-23 | Length 23 mm | In distribution | |
| P2SK-02-14 | Length 14 mm | In distribution | |
| SCE8-06-01 | Length 6 mm | In distribution | |
| 81-3015 | Length 8 mm | In distribution | |
| 81-3521[US] | Length 3 mm | 50 | In distribution |
| P3SB-04-20 | Length 20 mm | In distribution | |
| P4IP-04-17[US] | Length 17 mm | In distribution | |
| 81-3136[US] | Length 14 mm | In distribution | |
| 81-3131[US] | Length 14 mm | In distribution | |
| 81-2094 | In distribution | ||
| SCR2-14-05 | Length 14 mm | 5 | In distribution |
| 81-3035[US] | Length 18 mm | In distribution | |
| SCR4-04-05 | Length 4 mm | 5 | In distribution |
| 81-7304 | In distribution | ||
| SCD3-04-05 | Length 4 mm | 5 | In distribution |
| 81-3036-CP | Length 25 mm | 5 | In distribution |
| 81-5788 | Length 97 mm | In distribution | |
| SCE8-08-01 | Length 8 mm | In distribution | |
| 81-3031-CP | Length 16 mm | 5 | In distribution |
| 81-5785-CP | Length 99 mm | In distribution | |
| P2SB-02-11 | Length 11 mm | In distribution | |
| 81-3042 | Length 10 mm | 5 | In distribution |
| P4LL-05-28 | Length 28 mm | In distribution | |
| 81-5740 | Length 3 mm | 5 | In distribution |
| 81-3141-CP | Length 131 mm | In distribution | |
| 81-3025-CP | Length 65 mm | In distribution | |
| 81-3136-CP | Length 14 mm | In distribution | |
| 81-3581 | In distribution | ||
| SCR8-06-05 | Length 6 mm | 5 | In distribution |
| 81-3029-CP | Length 19 mm | 5 | In distribution |
| SCD2-04-05 | Length 4 mm | 5 | In distribution |
| 81-2067[US] | Length 5 mm | In distribution | |
| P2LW-07-23[US] | Length 23 mm | In distribution | |
| 81-5712 | In distribution | ||
| SCD8-03-05 | Length 3 mm | 5 | In distribution |
| SCE2-03-01 | Length 3 mm | In distribution | |
| 81-3043[US] | Length 5 mm | 5 | In distribution |
| 81-2076 | Length 4 mm | 5 | In distribution |
| 81-3528[US] | Length 14 mm | 50 | In distribution |
| 81-3579 | In distribution | ||
| SCR8-06-05[US] | Length 6 mm | 5 | In distribution |
| P2SW-24-95 | Length 95 mm | In distribution | |
| P8HP-11-18 | Length 16 mm | In distribution | |
| SCR8-04-05 | Length 4 mm | 5 | In distribution |
| 81-3022[US] | Length 60 mm | In distribution | |
| P2SB-02-14 | Length 14 mm | In distribution | |
| SCR4-13-05[US] | Length 13 mm | 5 | In distribution |
| P2XP-04-14 | Length 14 mm | In distribution | |
| 81-3040 | Length 6 mm | 5 | In distribution |
| 81-3161 | Length 86 mm | In distribution | |
| 81-5902 | In distribution | ||
| 81-3181-CP | Length 18 mm | 5 | In distribution |
| P2CK-06-32 | Length 32 mm | In distribution | |
| 81-3042[US] | Length 10 mm | 5 | In distribution |
| P4ST-16-99 | Length 100 mm | In distribution | |
| SCD2-03-05[US] | Length 3 mm | 5 | In distribution |
| SCD3-04-10 | Length 4 mm | 10 | In distribution |
| P2BX-04-14 | Length 14 mm | In distribution | |
| SCE4-06-05 | Length 6 mm | 5 | In distribution |
| 81-3048[US] | Length 12 mm | In distribution | |
| SCR8-10-01 | Length 10 mm | In distribution | |
| 81-3161[US] | Length 86 mm | In distribution | |
| P2HP-07-17 | Length 17 mm | In distribution | |
| SCR2-12-01 | Length 12 mm | In distribution | |
| 81-3011 | Length 3 mm | In distribution | |
| P2ZL-04-16 | Length 16 mm | In distribution | |
| 81-3488 | Length 16 mm | In distribution | |
| SCR2-03-05[US] | Length 3 mm | 5 | In distribution |
| 81-5890 | In distribution | ||
| SCE2-08-05 | Length 8 mm | 5 | In distribution |
| 81-3141 | Length 131 mm | In distribution | |
| P2YW-06-18 | Length 18 mm | In distribution | |
| SCR2-12-05 | Length 12 mm | 5 | In distribution |
| P4LL-04-24 | Length 24 mm | In distribution | |
| P2CB-06-27 | Length 27 mm | In distribution | |
| SCR2-05-05[US] | Length 5 mm | 5 | In distribution |
| 81-3053-CP | Length 8 mm | 10 | In distribution |
| P2SW-04-15 | Length 15 mm | In distribution | |
| SCE4-07-05[US] | Length 7 mm | 5 | In distribution |
| 81-3029 | Length 19 mm | In distribution | |
| 81-3493 | Length 4 mm | 5 | In distribution |
| 81-2002 | Length 18 mm | In distribution | |
| 81-3050-CP | Length 4 mm | 10 | In distribution |
| SCR4-12-05 | Length 12 mm | 5 | In distribution |
| 81-3048 | Length 12 mm | In distribution | |
| SCR4-13-05 | Length 13 mm | 5 | In distribution |
| 81-3059 | Length 30 mm | In distribution | |
| 81-5745 | Length 5 mm | In distribution | |
| P8CP-08-29 | Length 29 mm | In distribution | |
| SCD2-05-05[US] | Length 5 mm | 5 | In distribution |
| 81-3150 | Length 15 mm | In distribution | |
| 81-5915 | In distribution | ||
| P2RW-07-23[US] | Length 23 mm | In distribution | |
| 81-3149 | Length 22 mm | In distribution | |
| 81-2068[US] | Length 3 mm | In distribution | |
| 81-3049 | Length 3 mm | In distribution | |
| 81-2017 | Length 6 mm | 5 | In distribution |
| 81-3038 | Length 4 mm | 5 | In distribution |
| SCR8-10-05 | Length 10 mm | 5 | 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 |
| 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 |
|---|---|
| K082757 | 2008-10-01 |
| K051845 | 2005-07-27 |
| K031028 | 2003-04-28 |
| K030806 | 2003-04-08 |
| K023810 | 2002-12-04 |
| K023665 | 2002-11-22 |
| K022890 | 2002-09-06 |
| K022033 | 2002-07-19 |
| K021684 | 2002-06-26 |
| K013055 | 2001-12-07 |
| K012910 | 2001-11-20 |
| K011380 | 2001-05-14 |
| K002426 | 2001-01-26 |
| K994060 | 2001-01-24 |
| K002879 | 2000-10-05 |
| K001530 | 2000-07-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bioplate, Inc. | 510(k) number | 2010-03-31 | Not classified | Process design | There is potential defect in seal of the sterile barrier containing the device. | 16,020 Individual Kits; 2,226 Boxes. | 2012-04-04 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-09-12 | Not classified | Other | Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized. | 36 units | 2011-09-14 |
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.