Olympic
EGG, M, AO, Fixed, Aluminum Core, Internal, NON-Cannulated, Standard CAP
5manufacturers in China registered for this device type
684catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (2), Shanghai (1), Guangdong (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 |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
Record
| Listed by | Astura Medical, United States |
|---|---|
| FDA product code | OLO |
| Device type | Orthopedic Stereotaxic Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4560 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-06-01 |
| Record revised | 2025-12-10 (version 6) |
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 | Outer diameter 4.5 to 9.5 mm; length 20 to 600 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACKB55080 | Outer Diameter 5.5 mm | In distribution |
| AJJA65080 | Length 80 mm | In distribution |
| AJMA90070 | Length 70 mm | In distribution |
| ACJC55080 | Length 80 mm | In distribution |
| ACKB60080 | Outer Diameter 6.0 mm | In distribution |
| ACDA60070 | Outer Diameter 6.0 mm | In distribution |
| AJJA60045 | Length 45 mm | In distribution |
| AJFA75080 | Outer Diameter 7.5 mm | In distribution |
| AJJA55035 | Length 35 mm | In distribution |
| AJJA60040 | Length 40 mm | In distribution |
| ACJA55045 | Length 45 mm | In distribution |
| AZE330000 | In distribution | |
| ACDC55160 | Outer Diameter 5.5 mm | In distribution |
| AZE350000 | In distribution | |
| ACDA60085 | Outer Diameter 6.0 mm | In distribution |
| ACDC60500 | Outer Diameter 6.0 mm | In distribution |
| ACKB60200 | Outer Diameter 6.0 mm | In distribution |
| ACKA60080 | Outer Diameter 6.0 mm | In distribution |
| ACKC60060 | Outer Diameter 6.0 mm | In distribution |
| ACKC60200 | Outer Diameter 6.0 mm | In distribution |
| AJFA80035 | Outer Diameter 8.0 mm | In distribution |
| AJMA85080 | Length 80 mm | In distribution |
| ACJA55075 | Length 75 mm | In distribution |
| ACJC55085 | Length 85 mm | In distribution |
| AJJA65120 | Length 120 mm | In distribution |
| AJLA55045 | Length 45 mm | In distribution |
| AZA085000 | In distribution | |
| AJGA55030 | Length 30 mm | In distribution |
| ACJB60075 | Outer Diameter 6.0 mm | In distribution |
| AZA088075 | In distribution | |
| ACKB55150 | Outer Diameter 5.5 mm | In distribution |
| AZE190000 | In distribution | |
| ACJB55025 | Length 25 mm | In distribution |
| ACJA60060 | Outer Diameter 6.0 mm | In distribution |
| ACJC55020 | Length 20 mm | In distribution |
| ACKA60120 | Outer Diameter 6.0 mm | In distribution |
| AJLA65060 | Length 60 mm | In distribution |
| AZA091000 | In distribution | |
| AZA088045 | In distribution | |
| AZA084000 | In distribution | |
| ACJA55065 | Length 65 mm | In distribution |
| ACKC55300 | Outer Diameter 5.5 mm | In distribution |
| AJJA50045 | Length 45 mm | In distribution |
| AJMA85110 | Length 110 mm | In distribution |
| AJJA50050 | Length 50 mm | In distribution |
| AZA091001 | In distribution | |
| ACKA60090 | Outer Diameter 6.0 mm | In distribution |
| ACDB60600 | Outer Diameter 6.0 mm | In distribution |
| AJMA95110 | Length 110 mm | In distribution |
| AJJA70085 | Length 85 mm | In distribution |
| ACJB55060 | Length 60 mm | In distribution |
| ACDB55600 | Outer Diameter 5.5 mm | In distribution |
| AJFA75120 | Outer Diameter 7.5 mm | In distribution |
| ACDC55020 | Outer Diameter 5.5 mm | In distribution |
| AZA083000 | In distribution | |
| AJJA45040 | Length 40 mm | In distribution |
| ACDC60085 | Outer Diameter 6.0 mm | In distribution |
| ACJB55040 | Length 40 mm | In distribution |
| ACDA60095 | Outer Diameter 6.0 mm | In distribution |
| AJGA45030 | Length 30 mm | In distribution |
| ACDC55240 | Outer Diameter 5.5 mm | In distribution |
| ACKB60110 | Outer Diameter 6.0 mm | In distribution |
| AZE090004 | In distribution | |
| ACJA60065 | Outer Diameter 6.0 mm | In distribution |
| AZE410000 | In distribution | |
| AJFA85030 | Outer Diameter 8.5 mm | In distribution |
| AJMA70060 | Length 60 mm | In distribution |
| AJMA75040 | Length 40 mm | In distribution |
| ACJC60055 | Outer Diameter 6.0 mm | In distribution |
| ACJA55055 | Length 55 mm | In distribution |
| ACDC60200 | Outer Diameter 6.0 mm | In distribution |
| ACKA55090 | Outer Diameter 5.5 mm | In distribution |
| AZE090000 | In distribution | |
| AJBA80070 | Length 70 mm | In distribution |
| ACDC60040 | Outer Diameter 6.0 mm | In distribution |
| ACKA55300 | Outer Diameter 5.5 mm | In distribution |
| AZA089085 | In distribution | |
| AJJA55030 | Length 30 mm | In distribution |
| ACKA60070 | Outer Diameter 6.0 mm | In distribution |
| AJJA55065 | Length 65 mm | In distribution |
| AJFA80110 | Outer Diameter 8.0 mm | In distribution |
| AZA027000 | In distribution | |
| AJFA75095 | Outer Diameter 7.5 mm | In distribution |
| AJGA55020 | Length 20 mm | In distribution |
| ACDA60115 | Outer Diameter 6.0 mm | In distribution |
| ACJB60045 | Outer Diameter 6.0 mm | In distribution |
| AJJA65035 | Length 35 mm | In distribution |
| ACDB60085 | Outer Diameter 6.0 mm | In distribution |
| AJGA45055 | Length 55 mm | In distribution |
| ACKC55080 | Outer Diameter 5.5 mm | In distribution |
| AZE090002 | In distribution | |
| AJJA45025 | Length 25 mm | In distribution |
| ACDA60480 | Outer Diameter 6.0 mm | In distribution |
| ACJC55025 | Length 25 mm | In distribution |
| ACDA60105 | Outer Diameter 6.0 mm | In distribution |
| ACKA60110 | Outer Diameter 6.0 mm | In distribution |
| AJBA80080 | Length 80 mm | In distribution |
| AJJA70025 | Length 25 mm | In distribution |
| AJLA55055 | Length 55 mm | In distribution |
| AJMA95090 | Length 90 mm | In distribution |
| AJMA85030 | Length 30 mm | In distribution |
| ACKB60300 | Outer Diameter 6.0 mm | In distribution |
| AJFA75045 | Outer Diameter 7.5 mm | In distribution |
| ACJC55065 | Length 65 mm | In distribution |
| ACJB60065 | Outer Diameter 6.0 mm | In distribution |
| ACJA60115 | Outer Diameter 6.0 mm | In distribution |
| ACJB55110 | Length 110 mm | In distribution |
| AJLA55030 | Length 30 mm | In distribution |
| ACJC60095 | Outer Diameter 6.0 mm | In distribution |
| ACDC60095 | Outer Diameter 6.0 mm | In distribution |
| AZE630000 | In distribution | |
| ACKC60150 | Outer Diameter 6.0 mm | In distribution |
| ACDA60240 | Outer Diameter 6.0 mm | In distribution |
| AJFA80070 | Outer Diameter 8.0 mm | In distribution |
| ACDA60110 | Outer Diameter 6.0 mm | In distribution |
| ACDC60480 | Outer Diameter 6.0 mm | In distribution |
| AZE580000 | In distribution | |
| AZE520000 | In distribution | |
| AJMA95040 | Length 40 mm | In distribution |
| AJJA60035 | Length 35 mm | In distribution |
| AJMA75035 | Outer Diameter 7.5 mm | In distribution |
| AZE570000 | In distribution | |
| ACDB60095 | Outer Diameter 6.0 mm | In distribution |
| ACJA55110 | Length 110 mm | In distribution |
| AJMA90035 | Length 35 mm | In distribution |
| AZE310000 | In distribution | |
| AJJA45045 | Length 45 mm | In distribution |
| AZE280000 | In distribution | |
| AJJA65055 | Length 55 mm | In distribution |
| AJMA90110 | Length 110 mm | In distribution |
| ACDB60040 | Outer Diameter 6.0 mm | In distribution |
| AJGA45020 | Length 20 mm | In distribution |
| AJFA75075 | Outer Diameter 7.5 mm | In distribution |
| AJBA80065 | Length 65 mm | In distribution |
| ACDC55140 | Outer Diameter 5.5 mm | In distribution |
| AJFA75115 | Outer Diameter 7.5 mm | In distribution |
| AJFA80120 | Outer Diameter 8.0 mm | In distribution |
| AJJA60025 | Length 25 mm | In distribution |
| AJJA55055 | Length 55 mm | In distribution |
| ACJA55120 | Length 120 mm | In distribution |
| ACJC60110 | Outer Diameter 6.0 mm | In distribution |
| ACDB60055 | Outer Diameter 6.0 mm | In distribution |
| AJMA95035 | Length 35 mm | In distribution |
| ACKC55200 | Outer Diameter 5.5 mm | In distribution |
| ACDA60080 | Outer Diameter 6.0 mm | In distribution |
| ACKC60040 | Outer Diameter 6.0 mm | In distribution |
| AZE400000 | In distribution | |
| AJFA75035 | Outer Diameter 7.5 mm | In distribution |
| ACDC60300 | Outer Diameter 6.0 mm | In distribution |
| AJJA70095 | Length 95 mm | In distribution |
| ACDA60120 | Outer Diameter 6.0 mm | In distribution |
| ACJA55085 | Length 85 mm | In distribution |
| ACKB60070 | Outer Diameter 6.0 mm | In distribution |
| AJMA95065 | Length 65 mm | In distribution |
| AJMA70040 | Length 40 mm | In distribution |
| AJFA80080 | Outer Diameter 8.0 mm | In distribution |
| AJGA45060 | Length 60 mm | In distribution |
| AJJA45035 | Length 35 mm | In distribution |
| AJMA90120 | Length 120 mm | In distribution |
| AJFA75055 | Outer Diameter 7.5 mm | In distribution |
| ACJB60080 | Outer Diameter 6.0 mm | In distribution |
| AJJA45055 | Length 55 mm | In distribution |
| AJGA50020 | Length 20 mm | In distribution |
| AZE150000 | In distribution | |
| AJJA60050 | Length 50 mm | In distribution |
| AZA089055 | In distribution | |
| ACDA60140 | Outer Diameter 6.0 mm | In distribution |
| ACDC60030 | Outer Diameter 6.0 mm | In distribution |
| AZA091010 | In distribution | |
| ACDC60115 | Outer Diameter 6.0 mm | In distribution |
| ACJC55100 | Length 100 mm | In distribution |
| ACJA60045 | Outer Diameter 6.0 mm | In distribution |
| ACDC55025 | Outer Diameter 5.5 mm | In distribution |
| ACDC60120 | Outer Diameter 6.0 mm | In distribution |
| ACJC60045 | Outer Diameter 6.0 mm | In distribution |
| AJMA90090 | Length 90 mm | In distribution |
| AJLA60055 | Length 55 mm | In distribution |
| ACKC60080 | Outer Diameter 6.0 mm | In distribution |
| AZE480000 | In distribution | |
| AZE470000 | In distribution | |
| AJJA70115 | Length 115 mm | In distribution |
| AJJA65065 | Length 65 mm | In distribution |
| AJMA80050 | Length 50 mm | In distribution |
| ACDB60480 | Outer Diameter 6.0 mm | In distribution |
| AZA088090 | In distribution | |
| ACKA55070 | Outer Diameter 5.5 mm | In distribution |
| AZE490000 | In distribution | |
| AJJA70065 | Length 65 mm | In distribution |
| AJFA80105 | Outer Diameter 8.0 mm | In distribution |
| AJJA70070 | Length 70 mm | In distribution |
| ACJB55100 | Length 100 mm | In distribution |
| AJFA85065 | Outer Diameter 8.5 mm | In distribution |
| AZE400010 | In distribution | |
| ACJA55115 | Length 115 mm | In distribution |
| ACJB60085 | Outer Diameter 6.0 mm | In distribution |
| AZE100000-02 | In distribution | |
| ACJB60070 | Outer Diameter 6.0 mm | In distribution |
| AJFA75110 | Outer Diameter 7.5 mm | In distribution |
| ACKB55090 | Outer Diameter 5.5 mm | In distribution |
| ACKB55040 | Outer Diameter 5.5 mm | In distribution |
| ACKC55150 | Outer Diameter 5.5 mm | In distribution |
| ACJC60075 | Outer Diameter 6.0 mm | In distribution |
| ACJC60070 | Outer Diameter 6.0 mm | In distribution |
| AZE440000 | In distribution | |
| AJBA80085 | Length 85 mm | In distribution |
| AJJA70035 | Length 35 mm | In distribution |
| AZE340000 | In distribution | |
| AJFA80075 | Outer Diameter 8.0 mm | In distribution |
| AJMA85065 | Length 65 mm | In distribution |
| ACJB55095 | Length 95 mm | In distribution |
| AJJA65085 | Length 85 mm | In distribution |
| ACKB60060 | Outer Diameter 6.0 mm | In distribution |
| ACJA55025 | Length 25 mm | In distribution |
| ACDB60035 | Outer Diameter 6.0 mm | In distribution |
| ACDA60200 | Outer Diameter 6.0 mm | In distribution |
| ACKC55110 | Outer Diameter 5.5 mm | In distribution |
| ACDC55500 | Outer Diameter 5.5 mm | In distribution |
| ACJA55080 | Length 80 mm | In distribution |
| AZE500000-02 | In distribution | |
| AJGA50050 | Length 50 mm | In distribution |
| AJMA80040 | Length 40 mm | In distribution |
| ACDB60200 | Outer Diameter 6.0 mm | In distribution |
| ACJA60100 | Outer Diameter 6.0 mm | In distribution |
| ACKB55110 | Outer Diameter 5.5 mm | In distribution |
| AJJA50025 | Length 25 mm | In distribution |
| ACJC60035 | Outer Diameter 6.0 mm | In distribution |
| AJMA85045 | Length 45 mm | In distribution |
| EJZCMBBZZ | In distribution | |
| ACDA60160 | Outer Diameter 6.0 mm | In distribution |
| ACJB55070 | Length 70 mm | In distribution |
| AJMA90055 | Length 55 mm | In distribution |
| ACJC55095 | Length 95 mm | In distribution |
| ACDB60160 | Outer Diameter 6.0 mm | In distribution |
| ACDB60075 | Outer Diameter 6.0 mm | In distribution |
| AJMA90105 | Length 105 mm | In distribution |
| ACJC55050 | Length 50 mm | In distribution |
| ACDC60065 | Outer Diameter 6.0 mm | In distribution |
| ACJB55035 | Length 35 mm | In distribution |
| AJGA55025 | Length 25 mm | In distribution |
| ACDC60140 | Outer Diameter 6.0 mm | In distribution |
| AJJA45020 | Length 20 mm | In distribution |
| AZE560000 | In distribution | |
| ACDB60180 | Outer Diameter 6.0 mm | In distribution |
| ACJA60120 | Outer Diameter 6.0 mm | In distribution |
| AJMA90115 | Length 115 mm | In distribution |
| ACJC55070 | Length 70 mm | In distribution |
| AJMA90085 | Length 85 mm | In distribution |
| AJFA75090 | Outer Diameter 7.5 mm | In distribution |
| AJLA65065 | Outer Diameter 6.5 mm | In distribution |
| ACJA55030 | Length 30 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Excelsius GPS | Globus Medical, Inc. | 383 |
| Orthopedic Stereotaxic Instrument | Medtronic Navigation, Inc. | 356 |
| Masada | Astura Medical | 335 |
| Excelsiusgps | Globus Medical, Inc. | 297 |
| Invictus | Alphatec Spine, Inc. | 235 |
| OrthAlign Plus | OrthAlign, Inc. | 210 |
| Arvis ® | Kico Knee Innovation Company | 174 |
| OMNIBotics | Omni Life Science, Inc. | 150 |
| CD Horizon® Spinal System | Medtronic Sofamor Danek, Inc. | 137 |
| Navigation Instruments | VB Spine LLC | 135 |
| Orthopedic Stereotaxic Instrument | Mako Surgical Corp. | 124 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240160 | 2024-10-17 |
| K182982 | 2019-01-04 |
| K172166 | 2018-04-27 |
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.