Apollo Knee
Apollo BalanceBot Tibial Tray Trial Assembly - Large Right
5manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
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 | Corin Limited, United Kingdom |
|---|---|
| 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, Exporter |
| 510(k) | K231172 |
| Record published | 2024-12-18 |
| Record revised | 2026-03-19 (version 2) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TKR.BB.1400 | In distribution | |
| COR.TS.1300 | In distribution | |
| COR.TS.1900 | In distribution | |
| TKR.BB.1402 | In distribution | |
| TKR.OB.1100 | In distribution | |
| TKR.BB.1100 | In distribution | |
| TKR.IN.1331 | In distribution | |
| COR.ST.0011 | In distribution | |
| TKR.IN.1332 | In distribution | |
| TKR.BB.1703 | In distribution | |
| COR.ST.0001 | In distribution | |
| COR.TS.0015 | In distribution | |
| TKR.OB.1150 | In distribution | |
| TKR.BB.1101 | In distribution | |
| TKR.IN.1700 | In distribution | |
| TKR.BB.1500 | In distribution | |
| TKR.IN.1600 | In distribution | |
| TKR.KT.1300 | In distribution | |
| TKR.BB.1701 | In distribution | |
| TKR.BB.1403 | In distribution | |
| TKR.IN.1352 | In distribution | |
| TKR.IN.1342 | In distribution | |
| TKR.OB.1400 | In distribution | |
| TKR.OB.1201 | In distribution | |
| TKR.IN.1351 | In distribution | |
| TKR.BB.1705 | In distribution | |
| TKR.OB.1300 | In distribution | |
| COR.ST.0100 | In distribution | |
| TKR.OB.1000 | In distribution | |
| TKR.IN.1400 | In distribution | |
| TKR.BB.1401 | In distribution | |
| TKR.BB.1200 | In distribution | |
| TKR.BB.1706 | In distribution | |
| TKR.BB.1450 | In distribution | |
| COR.TS.1700 | In distribution | |
| TKR.SS.0001 | In distribution | |
| TKR.OB.1200 | In distribution | |
| TKR.BB.1704 | In distribution | |
| COR.TS.0005 | In distribution | |
| TKR.IN.1341 | In distribution | |
| TKR.OB.1900 | In distribution | |
| TKR.BB.1103 | In distribution | |
| TKR.BB.1702 | In distribution | |
| COR.TS.1600 | In distribution | |
| TKR.OB.1350 | In distribution | |
| TKR.IN.1800 | In distribution | |
| TKR.BB.1102 | In distribution | |
| TKR.BB.1700 | In distribution | |
| TKR.BB.1707 | In distribution | |
| TKR.BB.1000 | In distribution | |
| TKR.IN.1850 | In distribution | |
| COR.TS.1500 | In distribution | |
| COR.TS.1800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valence Robotic Navigation System | Alphatec Spine, Inc. | 813 |
| Olympic | Astura Medical | 684 |
| 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 |
Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200888 | 2020-06-27 |
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.