Olympic
High TOP Full Cortical Large Diameter Polyaxial Screw, Cannulated
7manufacturers in China registered for this device type
951catalogue 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 | Astura Medical, 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2018-02-19 |
| Record revised | 2025-12-10 (version 8) |
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 |
| Sizes | Length 15 to 600 mm; outer diameter 3.5 to 10.5 mm; width 5.5 to 9.5 mm; lumen/inner diameter 5.5 to 6 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AAAA70075 | Outer Diameter 7.0 mm | In distribution |
| AACA75045 | Outer Diameter 7.5 mm | In distribution |
| AAFA40030 | Outer Diameter 4.0 mm | In distribution |
| AANA85050 | Outer Diameter 8.5 mm | In distribution |
| AEKA55R24 | Length 300 mm | In distribution |
| AEKA63R04 | Length 100 mm | In distribution |
| ACAA55045 | Outer Diameter 5.5 mm | In distribution |
| AAUA60030 | Outer Diameter 6.0 mm | In distribution |
| AAKA85100 | Length 100 mm | In distribution |
| AAAA60020 | Outer Diameter 6.0 mm | In distribution |
| AACA90035 | Outer Diameter 9.0 mm | In distribution |
| AARA65035 | Outer Diameter 6.5 mm | In distribution |
| AABA65025 | Length 25 mm | In distribution |
| ACAC55600 | Outer Diameter 5.5 mm | In distribution |
| AAFA50060 | Length 60 mm | In distribution |
| AAUA55045 | Outer Diameter 5.5 mm | In distribution |
| AALA60060 | Outer Diameter 6.0 mm | In distribution |
| AACA70110 | Outer Diameter 7.0 mm | In distribution |
| AAMA95115 | Outer Diameter 9.5 mm | In distribution |
| AACA75095 | Outer Diameter 7.5 mm | In distribution |
| AA2A75060 | Length 60 mm | In distribution |
| ACAC60300 | Outer Diameter 6.0 mm | In distribution |
| ACAA60045 | Outer Diameter 6.0 mm | In distribution |
| ACAA55020 | Outer Diameter 5.5 mm | In distribution |
| ACAC60100 | Outer Diameter 6.0 mm | In distribution |
| AASA95110 | Outer Diameter 9.5 mm | In distribution |
| AASA05070 | Outer Diameter 10.5 mm | In distribution |
| AACA95115 | Outer Diameter 9.5 mm | In distribution |
| ACAA60085 | Outer Diameter 6.0 mm | In distribution |
| AAJA65050 | Length 50 mm | In distribution |
| AAQA70045 | Outer Diameter 7.0 mm | In distribution |
| ACAA55030 | Outer Diameter 5.5 mm | In distribution |
| AAAA70065 | Outer Diameter 7.0 mm | In distribution |
| ACBC55090 | Outer Diameter 5.5 mm | In distribution |
| AAJA65045 | Length 45 mm | In distribution |
| ACCB60050 | Outer Diameter 6.0 mm | In distribution |
| ACCB60070 | Outer Diameter 6.0 mm | In distribution |
| AAAA70085 | Outer Diameter 7.0 mm | In distribution |
| AALA65055 | Outer Diameter 6.5 mm | In distribution |
| AAFA55045 | Length 45 mm | In distribution |
| ACBC55095 | Outer Diameter 5.5 mm | In distribution |
| AAMA90120 | Outer Diameter 9.0 mm | In distribution |
| AEKA63R15 | RIGHT | In distribution |
| AASA05075 | Outer Diameter 10.5 mm | In distribution |
| AAMA05035 | Outer Diameter 10.5 mm | In distribution |
| AAMA85085 | Outer Diameter 8.5 mm | In distribution |
| ACCA55035 | Length 35 mm | In distribution |
| AEKA63R01 | Length 100 mm | In distribution |
| AATA90030 | Length 30 mm | In distribution |
| ACCB60110 | Outer Diameter 6.0 mm | In distribution |
| AENA63511 | DOUBLE | In distribution |
| AAJA60025 | Length 25 mm | In distribution |
| AAKA75075 | Length 75 mm | In distribution |
| AAQA40020 | Outer Diameter 4.0 mm | In distribution |
| ACAC60040 | Outer Diameter 6.0 mm | In distribution |
| ACCB55200 | Outer Diameter 5.5 mm | In distribution |
| AAUA65050 | Outer Diameter 6.5 mm | In distribution |
| AAKA85035 | Length 35 mm | In distribution |
| AASA90030 | Outer Diameter 9.0 mm | In distribution |
| AAEA50050 | Outer Diameter 5.0 mm | In distribution |
| AACA80040 | Outer Diameter 8.0 mm | In distribution |
| AANA85060 | Outer Diameter 8.5 mm | In distribution |
| AALA65060 | Outer Diameter 6.5 mm | In distribution |
| AAMA05115 | Outer Diameter 10.5 mm | In distribution |
| AAQA50055 | Outer Diameter 5.0 mm | In distribution |
| AAKA95060 | Outer Diameter 9.5 mm | In distribution |
| AAUA40055 | Outer Diameter 4.0 mm | In distribution |
| AACA80070 | Outer Diameter 8.0 mm | In distribution |
| AALA50025 | Outer Diameter 5.0 mm | In distribution |
| AAGA85080 | Length 80 mm | In distribution |
| ACCA55030 | Outer Diameter 5.5 mm | In distribution |
| AATA75095 | Outer Diameter 7.5 mm | In distribution |
| AAUA60055 | Outer Diameter 6.0 mm | In distribution |
| AAEA50055 | Outer Diameter 5.0 mm | In distribution |
| AALA45045 | Outer Diameter 4.5 mm | In distribution |
| ACBA55045 | Outer Diameter 5.5 mm | In distribution |
| AAJA65105 | Length 105 mm | In distribution |
| AACA95060 | Outer Diameter 9.5 mm | In distribution |
| AA3A65050 | Length 50 mm | In distribution |
| AAJA65020 | Length 20 mm | In distribution |
| AARA85100 | Outer Diameter 8.5 mm | In distribution |
| AACA00120 | Outer Diameter 10.0 mm | In distribution |
| AATA80070 | Outer Diameter 8.0 mm | In distribution |
| AAMA00030 | Outer Diameter 10.0 mm | In distribution |
| ACCC60110 | Length 110 mm | In distribution |
| AAFA60025 | Length 25 mm | In distribution |
| AAMA90080 | Outer Diameter 9.0 mm | In distribution |
| AEQA60005 | Length 15 mm | In distribution |
| AAHA60045 | Length 45 mm | In distribution |
| AACA75075 | Outer Diameter 7.5 mm | In distribution |
| ACAA60050 | Outer Diameter 6.0 mm | In distribution |
| AASA95050 | Outer Diameter 9.5 mm | In distribution |
| ACEA55001 | Outer Diameter 5.5 mm | In distribution |
| AAEA45040 | Outer Diameter 4.5 mm | In distribution |
| AAJA70070 | Length 70 mm | In distribution |
| AAMA75075 | Outer Diameter 7.5 mm | In distribution |
| AACA60055 | Outer Diameter 6.0 mm | In distribution |
| AANA65050 | Outer Diameter 6.5 mm | In distribution |
| ACBA55100 | Outer Diameter 5.5 mm | In distribution |
| ACCB55105 | Outer Diameter 5.5 mm | In distribution |
| AAQA45060 | Outer Diameter 4.5 mm | In distribution |
| ACCC55035 | Outer Diameter 5.5 mm | In distribution |
| AARA70035 | Outer Diameter 7.0 mm | In distribution |
| ACCB60095 | Length 95 mm | In distribution |
| AAJA45040 | Length 40 mm | In distribution |
| AAQA75025 | Outer Diameter 7.5 mm | In distribution |
| ACCA60095 | Outer Diameter 6.0 mm | In distribution |
| AAKA95105 | Outer Diameter 9.5 mm | In distribution |
| AAVA45060 | Outer Diameter 4.5 mm | In distribution |
| AAAA70095 | Outer Diameter 7.0 mm | In distribution |
| AANA80040 | Outer Diameter 8.0 mm | In distribution |
| AAKA80100 | Length 100 mm | In distribution |
| AARA65040 | Outer Diameter 6.5 mm | In distribution |
| AAMA00080 | Outer Diameter 10.0 mm | In distribution |
| AAKA95040 | Outer Diameter 9.5 mm | In distribution |
| AA2A80060 | Outer Diameter 8.0 mm | In distribution |
| ACCC55120 | Outer Diameter 5.5 mm | In distribution |
| AACA50060 | Outer Diameter 5.0 mm | In distribution |
| AADA50020 | Outer Diameter 5.0 mm | In distribution |
| AAQA60055 | Outer Diameter 6.0 mm | In distribution |
| AASA00035 | Outer Diameter 10.0 mm | In distribution |
| AA3A70055 | Outer Diameter 7.0 mm | In distribution |
| AATA85040 | Outer Diameter 8.5 mm | In distribution |
| AACA45030 | Outer Diameter 4.5 mm | In distribution |
| AEKA60R04 | Length 100 mm | In distribution |
| AAAA65115 | Outer Diameter 6.5 mm | In distribution |
| AACA00095 | Outer Diameter 10.0 mm | In distribution |
| AAQA60030 | Outer Diameter 6.0 mm | In distribution |
| AADA65060 | Outer Diameter 6.5 mm | In distribution |
| AADA55060 | Outer Diameter 5.5 mm | In distribution |
| AAWA40055 | Outer Diameter 4.0 mm | In distribution |
| AA4A70035 | Length 35 mm | In distribution |
| AACA80110 | Outer Diameter 8.0 mm | In distribution |
| AAJA70075 | Length 75 mm | In distribution |
| AAPA80030 | Outer Diameter 8.0 mm | In distribution |
| AEKA55R22 | Length 100 mm | In distribution |
| AASA00115 | Outer Diameter 10.0 mm | In distribution |
| ACCA55085 | Outer Diameter 5.5 mm | In distribution |
| AACA00070 | Outer Diameter 10.0 mm | In distribution |
| AAJA70095 | Length 95 mm | In distribution |
| AATA85100 | Outer Diameter 8.5 mm | In distribution |
| AAPA75055 | Outer Diameter 7.5 mm | In distribution |
| AAVA55035 | Outer Diameter 5.5 mm | In distribution |
| ACCA55105 | Outer Diameter 5.5 mm | In distribution |
| AATA90035 | Outer Diameter 9.0 mm | In distribution |
| AADA60025 | Outer Diameter 6.0 mm | In distribution |
| AAWA40060 | Outer Diameter 4.0 mm | In distribution |
| AAKA00110 | Outer Diameter 10.0 mm | In distribution |
| AAMA05030 | Outer Diameter 10.5 mm | In distribution |
| ACBA55055 | Outer Diameter 5.5 mm | In distribution |
| AA4A80040 | Outer Diameter 8.0 mm | In distribution |
| AAQA75050 | Outer Diameter 7.5 mm | In distribution |
| AAMA80045 | Outer Diameter 8.0 mm | In distribution |
| AALA45025 | Outer Diameter 4.5 mm | In distribution |
| AATA75040 | Outer Diameter 7.5 mm | In distribution |
| ACAA55080 | Outer Diameter 5.5 mm | In distribution |
| AANA65060 | Outer Diameter 6.5 mm | In distribution |
| AAAA40055 | Outer Diameter 4 mm | In distribution |
| AATA90115 | Outer Diameter 9.0 mm | In distribution |
| AAUA40050 | Outer Diameter 4.0 mm | In distribution |
| ACCC60070 | Outer Diameter 6.0 mm | In distribution |
| AAUA55040 | Outer Diameter 5.5 mm | In distribution |
| AAUA45045 | Outer Diameter 4.5 mm | In distribution |
| ACAC60120 | Outer Diameter 6.0 mm | In distribution |
| AAEA60060 | Outer Diameter 6.0 mm | In distribution |
| AA3A70040 | Length 40 mm | In distribution |
| AACA80120 | Outer Diameter 8.0 mm | In distribution |
| AEEA63514 | WIDE X-LARGE | In distribution |
| ACAA55120 | Outer Diameter 5.5 mm | In distribution |
| AADA40020 | Outer Diameter 4.0 mm | In distribution |
| AA4A80060 | Outer Diameter 8.0 mm | In distribution |
| AATA85120 | Outer Diameter 8.5 mm | In distribution |
| AAMA00070 | Outer Diameter 10.0 mm | In distribution |
| AACA70060 | Outer Diameter 7.0 mm | In distribution |
| ACBC60020 | Outer Diameter 6.0 mm | In distribution |
| AACA75055 | Outer Diameter 7.5 mm | In distribution |
| AA2A70055 | Length 55 mm | In distribution |
| AAAA65095 | Outer Diameter 6.5 mm | In distribution |
| ACBB55115 | Outer Diameter 5.5 mm | In distribution |
| AANA85120 | Outer Diameter 8.5 mm | In distribution |
| AAAA70020 | Outer Diameter 7.0 mm | In distribution |
| ACCB55030 | Outer Diameter 5.5 mm | In distribution |
| AATA90085 | Outer Diameter 9.0 mm | In distribution |
| ACBA55120 | Outer Diameter 5.5 mm | In distribution |
| ACCA60115 | Outer Diameter 6.0 mm | In distribution |
| AAAA70115 | Outer Diameter 7.0 mm | In distribution |
| AACA80100 | Outer Diameter 8.0 mm | In distribution |
| ACCC55040 | Outer Diameter 5.5 mm | In distribution |
| AAQA40045 | Outer Diameter 4.0 mm | In distribution |
| AASA05105 | Outer Diameter 10.5 mm | In distribution |
| AAQA50025 | Outer Diameter 5.0 mm | In distribution |
| AABA45060 | Length 60 mm | In distribution |
| AAMA75080 | Outer Diameter 7.5 mm | In distribution |
| AAJA65040 | Length 40 mm | In distribution |
| AAKA75040 | Length 40 mm | In distribution |
| AAKA90110 | Length 110 mm | In distribution |
| AACA65045 | Outer Diameter 6.5 mm | In distribution |
| AACA90030 | Outer Diameter 9.0 mm | In distribution |
| AAQA40050 | Outer Diameter 4.0 mm | In distribution |
| AAVA50045 | Outer Diameter 5.0 mm | In distribution |
| ACAA60030 | Outer Diameter 6.0 mm | In distribution |
| AAWA45040 | Outer Diameter 4.5 mm | In distribution |
| AACA00090 | Outer Diameter 10.0 mm | In distribution |
| AA3A65045 | Length 45 mm | In distribution |
| AAFA50020 | Length 20 mm | In distribution |
| AA1A80050 | Length 50 mm | In distribution |
| AACA70030 | Outer Diameter 7.0 mm | In distribution |
| AAJA70065 | Length 65 mm | In distribution |
| AADA60050 | Outer Diameter 6.0 mm | In distribution |
| ACCB55120 | Outer Diameter 5.5 mm | In distribution |
| AAAA45055 | Outer Diameter 4.5 mm | In distribution |
| AANA75050 | Outer Diameter 7.5 mm | In distribution |
| AASA85055 | Outer Diameter 8.5 mm | In distribution |
| AA4A65040 | Length 40 mm | In distribution |
| AAVA65040 | Outer Diameter 6.5 mm | In distribution |
| AACA95025 | Width 9.5 mm | In distribution |
| AAKA00075 | Outer Diameter 10.0 mm | In distribution |
| AEKA55R13 | Length 100 mm | In distribution |
| AACA65085 | Outer Diameter 6.5 mm | In distribution |
| AASA85035 | Outer Diameter 8.5 mm | In distribution |
| AACA00040 | Outer Diameter 10.0 mm | In distribution |
| AAMA95105 | Outer Diameter 9.5 mm | In distribution |
| AAMA75110 | Outer Diameter 7.5 mm | In distribution |
| AAQA55020 | Outer Diameter 5.5 mm | In distribution |
| ACCA60055 | Outer Diameter 6.0 mm | In distribution |
| AANA70055 | Outer Diameter 7.0 mm | In distribution |
| ACBC55105 | Outer Diameter 5.5 mm | In distribution |
| AEMA55006 | WIDE | In distribution |
| AASA05050 | Outer Diameter 10.5 mm | In distribution |
| AANA80035 | Outer Diameter 8.0 mm | In distribution |
| AAMA85110 | Outer Diameter 8.5 mm | In distribution |
| AA1A80045 | Length 45 mm | In distribution |
| AAAA65105 | Outer Diameter 6.5 mm | In distribution |
| AATA85095 | Length 95 mm | In distribution |
| AAJA65075 | Length 75 mm | In distribution |
| ACAC60200 | Outer Diameter 6.0 mm | In distribution |
| AA3A75055 | Outer Diameter 7.5 mm | In distribution |
| AASA00080 | Outer Diameter 10.0 mm | In distribution |
| AAMA85080 | Outer Diameter 8.5 mm | In distribution |
| AAKA75120 | Length 120 mm | In distribution |
| AAUA65055 | Outer Diameter 6.5 mm | In distribution |
| AAQA75055 | Outer Diameter 7.5 mm | In distribution |
| AEKA60R02 | Length 200 mm | In distribution |
| AADA40055 | Outer Diameter 4.0 mm | In distribution |
| AAQA55040 | Outer Diameter 5.5 mm | In distribution |
| AAKA90115 | Length 115 mm | In distribution |
| ACHA55550 | Outer Diameter 5.0 mm | In distribution |
| AACA65035 | Outer Diameter 6.5 mm | In distribution |
| AAEA65055 | Outer Diameter 6.5 mm | In distribution |
| AAVA60045 | Outer Diameter 6.0 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creo | Globus Medical, Inc. | 1,821 |
| ReLine | Nuvasive, Inc. | 1,093 |
| 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 |
| Polaris 4.75 TI Spinal System | Biomet Spine | 256 |
Showing 12 of 73. All products under Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153446 | 2016-04-08 |
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.