Revere
7.0mm/8.5mm REVERE 4.5 Closed REVERE Head Dual Outer Diameter Screw, 100mm
7manufacturers in China registered for this device type
212catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (2), Shanghai (1). 4 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 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Globus Medical, Inc., United States |
|---|---|
| FDA product code | OSH |
| Device type | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3070 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K113395 |
| Record published | 2015-10-27 |
| Record revised | 2025-07-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Outer diameter 4 to 10 mm; length 15 to 700 mm; width 7.5 to 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1041.3090 | Length 90 mm | In distribution |
| 1041.8775 | Outer Diameter 9 mm | In distribution |
| 1041.4655 | Length 55 mm | In distribution |
| 1041.9401 | Length 31 mm | In distribution |
| 1041.8974 | Outer Diameter 8.5 mm | In distribution |
| 1041.9975 | In distribution | |
| 1041.5637 | Length 37 mm | In distribution |
| 1041.3955 | Length 55 mm | In distribution |
| 1041.9330 | Length 100 mm | In distribution |
| 1041.9214 | Length 110 mm | In distribution |
| 1041.6097 | Length 110 mm | In distribution |
| 1041.9945 | In distribution | |
| 1041.5409 | Length 45 mm | In distribution |
| 1041.8498 | Outer Diameter 7.5 mm | In distribution |
| 1041.8940 | Outer Diameter 6.5 mm | In distribution |
| 1041.8950 | Length 80 mm | In distribution |
| 1041.8961 | Outer Diameter 8.5 mm | In distribution |
| 1041.7798 | Length 120 mm | In distribution |
| 1041.5755 | Length 55 mm | In distribution |
| 1041.8435 | Length 35 mm | In distribution |
| 1041.9352 | Length 25 mm | In distribution |
| 1041.5500 | Length 20 mm | In distribution |
| 1041.8913 | Outer Diameter 7 mm | In distribution |
| 7041.0465 | Length 600 mm | In distribution |
| 1041.8255 | Outer Diameter 6.5 mm | In distribution |
| 1041.0025 | Length 25 mm | In distribution |
| 1041.3430 | Length 30 mm | In distribution |
| 1041.4670 | Outer Diameter 6.5 mm | In distribution |
| 1041.7875 | Length 75 mm | In distribution |
| 1041.8931 | Outer Diameter 7.5 mm | In distribution |
| 7041.1045 | Outer Diameter 4.5 mm | In distribution |
| 7041.0045 | Outer Diameter 4.5 mm | In distribution |
| 1041.9025 | Length 25 mm | In distribution |
| 1041.4440 | Length 40 mm | In distribution |
| 7041.1025 | Outer Diameter 4.5 mm | In distribution |
| 1041.8655 | Length 55 mm | In distribution |
| 1041.0455 | Length 600 mm | In distribution |
| 1041.5660 | Outer Diameter 6.5 mm | In distribution |
| 1041.4650 | Length 50 mm | In distribution |
| 1041.3660 | Length 60 mm | In distribution |
| 1041.8260 | Outer Diameter 6.5 mm | In distribution |
| 1041.8735 | Outer Diameter 9 mm | In distribution |
| 1041.3975 | Outer Diameter 9 mm | In distribution |
| 1041.9970 | In distribution | |
| 1041.7920 | Outer Diameter 9 mm | In distribution |
| 1041.8902 | Length 40 mm | In distribution |
| 1041.5502 | Outer Diameter 5 mm | In distribution |
| 1041.1035 | Length 35 mm | In distribution |
| 1041.9983 | In distribution | |
| 1041.4895 | Length 95 mm | In distribution |
| 1041.9224 | Length 110 mm | In distribution |
| 1041.1700 | Outer Diameter 4.5 mm | In distribution |
| 1041.5885 | Length 85 mm | In distribution |
| 1041.8798 | Outer Diameter 9 mm | In distribution |
| 1041.5401 | Length 22 mm | In distribution |
| 7041.2050 | Length 50 mm | In distribution |
| 1041.8595 | Outer Diameter 5.5 mm | In distribution |
| 1041.8713 | Outer Diameter 8.5 mm | In distribution |
| 1041.8992 | Outer Diameter 9 mm | In distribution |
| 1041.3560 | Length 60 mm | In distribution |
| 1041.3680 | Outer Diameter 6.5 mm | In distribution |
| 1041.5096 | Outer Diameter 10 mm | In distribution |
| 1041.8695 | Outer Diameter 8 mm | In distribution |
| 1041.9830 | Outer Diameter 4.5 mm | In distribution |
| 1041.8702 | Outer Diameter 8.5 mm | In distribution |
| 1041.9971 | In distribution | |
| 7041.0095 | Length 95 mm | In distribution |
| 1041.8075 | Outer Diameter 5.5 mm | In distribution |
| 1041.7507 | Outer Diameter 5 mm | In distribution |
| 1041.4840 | Outer Diameter 8.5 mm | In distribution |
| 7041.0300 | Length 300 mm | In distribution |
| 1041.8944 | Length 50 mm | In distribution |
| 1041.2060 | Length 60 mm | In distribution |
| 1041.3030 | Length 30 mm | In distribution |
| 1041.0090 | Outer Diameter 4.5 mm | In distribution |
| 1041.3665 | Length 65 mm | In distribution |
| 7041.1040 | Outer Diameter 4.5 mm | In distribution |
| 1041.8312 | Outer Diameter 7 mm | In distribution |
| 1041.9840 | Width 10 mm | In distribution |
| 1041.5510 | Outer Diameter 5 mm | In distribution |
| 1041.4850 | Length 50 mm | In distribution |
| 1041.8986 | Length 60 mm | In distribution |
| 1041.8480 | Outer Diameter 9 mm | In distribution |
| 1041.5532 | Length 32 mm | In distribution |
| 1041.5985 | Length 85 mm | In distribution |
| 1041.4797 | Length 110 mm | In distribution |
| 1041.8612 | Length 80 mm | In distribution |
| 1041.6055 | Length 55 mm | In distribution |
| 1041.9905 | In distribution | |
| 1041.4503 | Outer Diameter 5 mm | In distribution |
| 7041.0125 | Outer Diameter 4.5 mm | In distribution |
| 1041.8316 | Outer Diameter 8.5 mm | In distribution |
| 1041.4450 | Length 50 mm | In distribution |
| 1041.3998 | Outer Diameter 9 mm | In distribution |
| 1041.7860 | Length 60 mm | In distribution |
| 1041.3897 | Length 110 mm | In distribution |
| 1041.5930 | Outer Diameter 9 mm | In distribution |
| 7041.1600 | Outer Diameter 4.5 mm | In distribution |
| 1041.9212 | Length 70 mm | In distribution |
| 1041.8035 | Outer Diameter 7 mm | In distribution |
| 1041.8313 | Outer Diameter 7 mm | In distribution |
| 1041.3080 | Length 80 mm | In distribution |
| 1041.6095 | Length 95 mm | In distribution |
| 1041.5030 | Outer Diameter 10 mm | In distribution |
| 1041.8941 | Length 35 mm | In distribution |
| 1041.6065 | Outer Diameter 10 mm | In distribution |
| 1041.4696 | Length 100 mm | In distribution |
| 1041.8797 | Outer Diameter 7.5 mm | In distribution |
| 1041.4860 | Outer Diameter 8.5 mm | In distribution |
| 1041.5627 | Length 27 mm | In distribution |
| 1041.9848 | Outer Diameter 6.5 mm | In distribution |
| 1041.5525 | Length 25 mm | In distribution |
| 1041.8306 | Outer Diameter 8.5 mm | In distribution |
| 1041.7970 | Outer Diameter 9 mm | In distribution |
| 1041.8810 | Outer Diameter 8 mm | In distribution |
| 1041.9002 | Length 20 mm | In distribution |
| 1041.3875 | Length 75 mm | In distribution |
| 1041.9838 | Outer Diameter 6.5 mm | In distribution |
| 1041.5760 | Outer Diameter 7.5 mm | In distribution |
| 1041.8969 | Outer Diameter 8.5 mm | In distribution |
| 1041.3785 | Length 85 mm | In distribution |
| 1041.4940 | Length 40 mm | In distribution |
| 1041.2025 | Length 25 mm | In distribution |
| 1041.5504 | Outer Diameter 5 mm | In distribution |
| 1041.9304 | Length 35 mm | In distribution |
| 1041.8708 | Outer Diameter 7 mm | In distribution |
| 1041.9306 | Length 45 mm | In distribution |
| 1041.8311 | Outer Diameter 8.5 mm | In distribution |
| 1041.4980 | Length 80 mm | In distribution |
| 7041.2085 | Outer Diameter 4.5 mm | In distribution |
| 1041.3065 | Length 65 mm | In distribution |
| 7041.2125 | Length 125 mm | In distribution |
| 1041.5025 | Outer Diameter 10 mm | In distribution |
| 1041.8470 | Length 70 mm | In distribution |
| 1041.4535 | Length 35 mm | In distribution |
| 1041.2080 | Length 80 mm | In distribution |
| 1041.9520 | Length 500 mm | In distribution |
| 1041.4770 | Outer Diameter 7.5 mm | In distribution |
| 1041.9836 | Width 7.5 mm | In distribution |
| 1041.9904 | In distribution | |
| 1041.4550 | Length 50 mm | In distribution |
| 1041.4565 | Length 65 mm | In distribution |
| 1041.3098 | Outer Diameter 10 mm | In distribution |
| 1041.5997 | Length 110 mm | In distribution |
| 1041.3507 | Length 55 mm | In distribution |
| 1041.7635 | Length 35 mm | In distribution |
| 1041.0700 | Length 700 mm | In distribution |
| 1041.5897 | Length 110 mm | In distribution |
| 1041.8302 | Length 30 mm | In distribution |
| 1041.8104 | Outer Diameter 6 mm | In distribution |
| 1041.8967 | Length 65 mm | In distribution |
| 1041.3840 | Length 40 mm | In distribution |
| 1041.8065 | Outer Diameter 5.5 mm | In distribution |
| 1041.8309 | Outer Diameter 8.5 mm | In distribution |
| 1041.8050 | Length 50 mm | In distribution |
| 1041.8906 | Outer Diameter 7 mm | In distribution |
| 1041.7720 | Outer Diameter 7.5 mm | In distribution |
| 1041.7403 | Outer Diameter 4 mm | In distribution |
| 1041.8108 | Outer Diameter 7.5 mm | In distribution |
| 1041.4745 | Length 45 mm | In distribution |
| 1041.7402 | Length 30 mm | In distribution |
| 7041.0035 | Outer Diameter 4.5 mm | In distribution |
| 1041.8298 | Outer Diameter 6.5 mm | In distribution |
| 1041.8923 | Outer Diameter 7.5 mm | In distribution |
| 1041.9941 | In distribution | |
| 1041.9513 | Length 325 mm | In distribution |
| 1041.4935 | Outer Diameter 9 mm | In distribution |
| 7041.0060 | Outer Diameter 4.5 mm | In distribution |
| 1041.9502 | In distribution | |
| 1041.4960 | Length 60 mm | In distribution |
| 7041.0065 | Outer Diameter 4.5 mm | In distribution |
| 1041.7525 | Length 25 mm | In distribution |
| 1041.3670 | Length 70 mm | In distribution |
| 1041.1200 | Length 200 mm | In distribution |
| 1041.7765 | Length 65 mm | In distribution |
| 1041.6030 | Length 30 mm | In distribution |
| 1041.9944 | In distribution | |
| 1041.3870 | Length 70 mm | In distribution |
| 7041.1080 | Length 80 mm | In distribution |
| 1041.8901 | Outer Diameter 7 mm | In distribution |
| 1041.8555 | Length 55 mm | In distribution |
| 1041.1125 | Outer Diameter 4.5 mm | In distribution |
| 1041.5965 | Length 65 mm | In distribution |
| 1041.8965 | Outer Diameter 7 mm | In distribution |
| 1041.7925 | Outer Diameter 9 mm | In distribution |
| 1041.7796 | Outer Diameter 7.5 mm | In distribution |
| 1041.9225 | Length 130 mm | In distribution |
| 1041.3898 | Length 120 mm | In distribution |
| 1041.4996 | Outer Diameter 9 mm | In distribution |
| 1041.7895 | Length 95 mm | In distribution |
| 1041.5990 | Outer Diameter 9 mm | In distribution |
| 1041.7500 | Length 20 mm | In distribution |
| 1041.7425 | Length 25 mm | In distribution |
| 1041.9320 | Length 15 mm | In distribution |
| 1041.8770 | Outer Diameter 9 mm | In distribution |
| 1041.5400 | Outer Diameter 4 mm | In distribution |
| 1041.8949 | Outer Diameter 8 mm | In distribution |
| 1041.7435 | Length 35 mm | In distribution |
| 1041.9833 | Width 7.5 mm | In distribution |
| 1041.5507 | Outer Diameter 5 mm | In distribution |
| 7041.2100 | Length 100 mm | In distribution |
| 1041.3690 | Length 90 mm | In distribution |
| 1041.8982 | Outer Diameter 7.5 mm | In distribution |
| 1041.1040 | Length 40 mm | In distribution |
| 1041.4897 | Outer Diameter 8.5 mm | In distribution |
| 1041.8113 | Length 85 mm | In distribution |
| 1041.5065 | Outer Diameter 10 mm | In distribution |
| 1041.4406 | Outer Diameter 4 mm | In distribution |
| 1041.3675 | Length 75 mm | In distribution |
| 1041.7935 | Outer Diameter 9 mm | In distribution |
| 1041.8988 | Length 70 mm | In distribution |
| 1041.9503 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| Olympic | Astura Medical | 951 |
| Nex-D2 | Next Orthosurgical | 887 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 876 |
| Arsenal | Alphatec Spine, Inc. | 820 |
| Apex-DL Spine System | Spinecraft LLC | 691 |
| Polaris™ 4.75 Spinal System | Biomet Spine | 413 |
| Expedium | Medos International Sàrl | 400 |
| Implanet Spine System | Implanet | 386 |
| Everest® Spinal System | VB Spine LLC | 299 |
| Arsenal Deformity Spinal Fixation System | Alphatec Spine, Inc. | 258 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K124058 | 2013-05-13 |
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.