Olympic

High TOP Full Cortical Large Diameter Polyaxial Screw, Cannulated

Registry build 21.09.26
13manufacturers in China registered for this device type
1,173catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (7), Shanghai (2), Shandong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code MNH
Manufacturer City Province Registered as Device types
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
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
Shandong Weigao Orthopaedic Device Co., Ltd. Weihai Shandong Contract manufacturer 42
Johnson & Johnson Medical (Depuy – Suzhou) Ltd. Suzhou Jiangsu Manufacturer 34
Double Medical Technology Inc. Xiamen Fujian Contract manufacturer 14
Suzhou Kangli Orthopaedics Instrument Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 11
Changzhou Yonghua Medical Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 8
Jiangsu Ideal Medical Science & Technology Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 7

Showing 12 of 13. All 13 manufacturers in China registered for Orthosis, Spondylolisthesis Spinal Fixation

Record

Regulatory record for Olympic
Listed by Astura Medical, United States
FDA product code MNH
Device type Orthosis, Spondylolisthesis Spinal Fixation
Device class Class 2
Regulation 21 CFR 888.3070
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2016-09-23
Record revised 2025-12-10 (version 8)

Specifications

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 3.5 to 610 mm; outer diameter 3.5 to 10.5 mm; lumen/inner diameter 3.5 to 6.35 mm; width 3.5 to 9.5 mm; depth 6 mm; outer diameter 5.5 µm

Catalogue Numbers

Catalogue numbers for Olympic
Catalogue number Size Status
ACBB60040 Length 40 mm In distribution
ACBA60035 Length 35 mm In distribution
AADA45030 Length 30 mm In distribution
AAYA50060 Outer Diameter 5.0 mm In distribution
AAZA70030 Outer Diameter 7.0 mm In distribution
ACAA55035 Length 35 mm In distribution
ACBC60115 Outer Diameter 6.0 mm In distribution
AAGA70055 Outer Diameter 7.0 mm In distribution
AACA75020 Length 20 mm In distribution
ACAB60025 Length 25 mm In distribution
ACCB55115 Length 115 mm In distribution
ACCA60030 Length 30 mm In distribution
AAQA65035 Length 35 mm In distribution
ABAA00060 Outer Diameter 6.0 mm In distribution
AACA80105 Length 105 mm In distribution
AASA95055 Length 55 mm In distribution
AAAA45025 Length 25 mm In distribution
AEHA55002 Lumen/Inner Diameter 6 mm In distribution
AAZA40030 Outer Diameter 4.0 mm In distribution
AEKA63R16 Length 100 mm In distribution
AACA80115 Length 115 mm In distribution
AASA95060 Length 60 mm In distribution
ACCB60105 Outer Diameter 6.0 mm In distribution
AATA80080 Length 80 mm In distribution
AEKA63L16 WIDE In distribution
AAJA60040 Length 40 mm In distribution
AAWA60045 Outer Diameter 6.0 mm In distribution
AEKA55L05 Length 200 mm In distribution
AAAA65110 Length 110 mm In distribution
AEJA63L05 Width 6.35 mm In distribution
AADA45045 Length 45 mm In distribution
AAHA70050 Length 50 mm In distribution
AAVA60030 Length 30 mm In distribution
AAYA55050 Outer Diameter 5.5 mm In distribution
AADA45035 Length 35 mm In distribution
ACBC60080 Outer Diameter 6.0 mm In distribution
AEJA55R04 Width 5.5 mm In distribution
AASA80100 Length 100 mm In distribution
AABA70040 Length 40 mm In distribution
AATA95035 Length 35 mm In distribution
AEEA55001 Lumen/Inner Diameter 5.5 mm In distribution
AEKA55R09 Length 300 mm In distribution
AAYA55045 Outer Diameter 5.5 mm In distribution
ACAC60105 Length 105 mm In distribution
AAAA60060 Length 60 mm In distribution
AAHA45060 Outer Diameter 4.5 mm In distribution
AABA70035 Length 35 mm In distribution
AAVA55020 Length 20 mm In distribution
AAWA50025 Outer Diameter 5.0 mm In distribution
AABA70050 Length 50 mm In distribution
AAZA45030 Outer Diameter 4.5 mm In distribution
AASA85075 Length 75 mm In distribution
ACAB60080 Length 80 mm In distribution
AEKA63L10 WIDE In distribution
AACA85020 Length 20 mm In distribution
AEKA60L04 Length 100 mm In distribution
AACA05100 Length 100 mm In distribution
AAGA75050 Outer Diameter 7.5 mm In distribution
AAGA75045 Outer Diameter 7.5 mm In distribution
AA4A75030 Length 30 mm In distribution
AAZA50050 Outer Diameter 5.0 mm In distribution
AACA75110 Length 110 mm In distribution
AELA35106 Lumen/Inner Diameter 6.35 mm In distribution
ACAC60045 Length 45 mm In distribution
AEBA60060 Length 60 mm In distribution
AAHA55020 Outer Diameter 5.5 mm In distribution
AAAA70060 Length 60 mm In distribution
AARA75040 Length 40 mm In distribution
AAAA70045 Length 45 mm In distribution
ACBB55120 Length 120 mm In distribution
ACAC55030 Length 30 mm In distribution
AEHA55003 Lumen/Inner Diameter 6.35 mm In distribution
AA3A80060 Length 60 mm In distribution
AACA65060 Length 60 mm In distribution
AAAA70050 Length 50 mm In distribution
AEJA55R11 Width 5.5 mm In distribution
AATA85045 Length 45 mm In distribution
AEHA35101 Lumen/Inner Diameter 5.5 mm In distribution
AEKA55L09 Length 300 mm In distribution
AEJA55L04 Width 5.5 mm In distribution
AAJA70030 Length 30 mm In distribution
AATA90075 Outer Diameter 9.0 mm In distribution
AA3A75035 Length 35 mm In distribution
AAYA45055 Outer Diameter 4.5 mm In distribution
ACAB60030 Length 30 mm In distribution
AEKA55L22 Length 100 mm In distribution
AEKA55L10 Length 100 mm In distribution
AEEA55012 Lumen/Inner Diameter 5.5 mm In distribution
ACBB55040 Length 40 mm In distribution
ACAC60085 Length 85 mm In distribution
AACA70025 Length 25 mm In distribution
AABA60045 Length 45 mm In distribution
AAFA60040 Outer Diameter 6.0 mm In distribution
AABA45030 Length 30 mm In distribution
AAHA60030 Length 30 mm In distribution
AAFA40040 Length 40 mm In distribution
ACCC60115 Outer Diameter 6.0 mm In distribution
AAGA80045 Outer Diameter 8.0 mm In distribution
ACAC60500 Length 500 mm In distribution
ADBA00036 Length 36 mm In distribution
AACA90080 Length 80 mm In distribution
AEKA63L06 WIDE In distribution
ADAA55001 In distribution
AAZA45060 Outer Diameter 4.5 mm In distribution
AEKA63L14 STD In distribution
AAEA50035 Length 35 mm In distribution
AEEA55013 Width 5.5 mm In distribution
AATA95030 Outer Diameter 9.5 mm In distribution
AAFA45060 Outer Diameter 4.5 mm In distribution
AEEA55015 Width 5.5 mm In distribution
AEKA55L03 Length 300 mm In distribution
AAFA60030 Outer Diameter 6.0 mm In distribution
ACAA55115 Length 115 mm In distribution
AABA70030 Length 30 mm In distribution
AAUA50035 Length 35 mm In distribution
AEJA63L15 Width 6.35 mm In distribution
AASA75115 Length 115 mm In distribution
ACBA60040 Length 40 mm In distribution
AACA05070 Length 70 mm In distribution
AEMA55014 Outer Diameter 6.0 mm In distribution
AASA85040 Length 40 mm In distribution
AENA55001 Lumen/Inner Diameter 5.5 mm In distribution
AAWA40035 Length 35 mm In distribution
AATA05085 Outer Diameter 10.5 mm In distribution
AADA55020 Length 20 mm In distribution
AATA00065 Outer Diameter 10.0 mm In distribution
AARA65050 Length 50 mm In distribution
AADA60055 Length 55 mm In distribution
ACAB55100 Length 100 mm In distribution
ACAB55050 Length 50 mm In distribution
AAWA60050 Outer Diameter 6.0 mm In distribution
AACA00035 Length 35 mm In distribution
AARA65045 Length 45 mm In distribution
AACA70115 Length 115 mm In distribution
AEJA55L15 Width 5.5 mm In distribution
AARA80030 Length 30 mm In distribution
AACA05020 Length 20 mm In distribution
AABA60060 Length 60 mm In distribution
AAAA40045 Length 45 mm In distribution
AAEA60050 Length 50 mm In distribution
ACAB55500 Length 500 mm In distribution
AACA70035 Length 35 mm In distribution
AEKA55R21 Length 300 mm In distribution
AEKA55R04 WIDE In distribution
AAAA65070 Length 70 mm In distribution
AAAA50045 Length 45 mm In distribution
AATA85075 Length 75 mm In distribution
ACBC60025 Outer Diameter 6.0 mm In distribution
AA4A70040 Length 40 mm In distribution
AAYA50020 Outer Diameter 5.0 mm In distribution
AAHA45055 Outer Diameter 4.5 mm In distribution
AASA85085 Length 85 mm In distribution
ACAB55060 Length 60 mm In distribution
AATA00095 Outer Diameter 10.0 mm In distribution
AAWA60060 Outer Diameter 6.0 mm In distribution
AABA50065 Length 60 mm In distribution
AATA05040 Outer Diameter 10.5 mm In distribution
AEGA35101 Lumen/Inner Diameter 5.5 mm In distribution
ACAC55050 Length 50 mm In distribution
ACBB60045 Length 45 mm In distribution
AATA90070 Length 70 mm In distribution
AAVA65060 Length 60 mm In distribution
AEKA63L20 STD In distribution
AACA85065 Length 65 mm In distribution
AACA85085 Length 85 mm In distribution
ACCB55035 Length 35 mm In distribution
AEGA35103 Lumen/Inner Diameter 6.35 mm In distribution
AEBA60030 Length 30 mm In distribution
AACA80065 Length 65 mm In distribution
ACAB60600 Length 600 mm In distribution
AAAA60035 Length 35 mm In distribution
AATA95085 Outer Diameter 9.5 mm In distribution
AA4A70055 Length 55 mm In distribution
AASA90120 Length 120 mm In distribution
AEKA63R12 Length 300 mm In distribution
AASA80080 Length 80 mm In distribution
AAQA60050 Length 50 mm In distribution
AASA95085 Length 85 mm In distribution
AAYA65055 Outer Diameter 6.5 mm In distribution
AACA80075 Length 75 mm In distribution
AEQA60014 Length 25 mm In distribution
AASA80120 Length 120 mm In distribution
AAQA50050 Length 50 mm In distribution
AAEA65040 Length 40 mm In distribution
AAYA45045 Outer Diameter 4.5 mm In distribution
AAYA55055 Outer Diameter 5.5 mm In distribution
AATA00085 Outer Diameter 10.0 mm In distribution
AEFA63512 Width 6.35 mm In distribution
ACCA60045 Length 45 mm In distribution
AABA45045 Length 45 mm In distribution
ACCA55070 Length 70 mm In distribution
ADBA00040 Length 40 mm In distribution
AACA70105 Length 105 mm In distribution
AAUA55030 Length 30 mm In distribution
AEKA60L18 WIDE In distribution
AAWA55035 Outer Diameter 5.5 mm In distribution
ACAA55075 Length 75 mm In distribution
AAAA40065 Length 65 mm In distribution
ACCC60100 Outer Diameter 6.0 mm In distribution
AAQA60045 Length 45 mm In distribution
ACAA60115 Length 115 mm In distribution
AATA85085 Length 85 mm In distribution
ACAB60050 Length 50 mm In distribution
ACEA55006 Length 300 mm In distribution
AAHA55025 Outer Diameter 5.5 mm In distribution
AEAA55015 Length 15 mm In distribution
AAHA70060 Length 60 mm In distribution
AARA70040 Length 40 mm In distribution
AA4A65055 Outer Diameter 6.5 mm In distribution
AARA85035 Length 35 mm In distribution
AAQA55035 Length 35 mm In distribution
AAEA60055 Length 55 mm In distribution
AAVA65030 Length 30 mm In distribution
AABA60025 Outer Diameter 6.0 mm In distribution
AATA75115 Length 115 mm In distribution
ACAA60035 Length 35 mm In distribution
AELA35102 Lumen/Inner Diameter 5.5 mm In distribution
AABA45025 Outer Diameter 4.5 mm In distribution
AAFA55020 Outer Diameter 5.5 mm In distribution
ACEA60004 Length 100 mm In distribution
AAGA80035 Outer Diameter 8.0 mm In distribution
AAGA65060 Outer Diameter 6.5 mm In distribution
AATA90100 Length 100 mm In distribution
ACCA55120 Length 120 mm In distribution
AEKA55L19 Length 100 mm In distribution
ACCB60060 Length 60 mm In distribution
ADBA00025 Length 25 mm In distribution
AEJA63R01 Width 6.35 mm In distribution
AAWA50020 Outer Diameter 5.0 mm In distribution
AACA65120 Length 120 mm In distribution
AAGA85035 Outer Diameter 8.5 mm In distribution
ACCC55600 Length 600 mm In distribution
AATA80050 Length 50 mm In distribution
AABA55055 Outer Diameter 5.5 mm In distribution
AAAA70110 Length 110 mm In distribution
AAJA60045 Length 45 mm In distribution
AAZA55040 Outer Diameter 5.5 mm In distribution
AAAA50050 Length 50 mm In distribution
AATA85080 Outer Diameter 8.5 mm In distribution
AAVA60035 Length 35 mm In distribution
AEJA55R06 Width 5.5 mm In distribution
AEKA63R20 Length 200 mm In distribution
AEFA55002 WIDE In distribution
ACBB60115 Length 115 mm In distribution
AABA55045 Outer Diameter 5.5 mm In distribution
AAZA60050 Outer Diameter 6.0 mm In distribution
AEEA63502 Lumen/Inner Diameter 6.35 mm In distribution
AATA95055 Outer Diameter 9.5 mm In distribution
AAHA65115 Outer Diameter 6.5 mm In distribution
ACBA60120 Length 120 mm In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
CD Horizon® Spinal System Medtronic Sofamor Danek, Inc. 3,144
Anax™ 5.5 Spinal System CG MedTech Co., Ltd. 2,177
ReLine Nuvasive, Inc. 2,010
Creo Globus Medical, Inc. 1,619
Perfix™ Spinal System CG MedTech Co., Ltd. 1,476
Apex Spine System Spinecraft LLC 1,193
Arsenal Alphatec Spine, Inc. 1,001
Revere Globus Medical, Inc. 997
Astra Spine System Spinecraft LLC 798
Apex-DL Spine System Spinecraft LLC 735
Zenius Spinal System Medyssey Co., Ltd. 712
Polaris 5.5 Spinal System Biomet Spine 707

Showing 12 of 811. All products under Orthosis, Spondylolisthesis Spinal Fixation

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer