Apex INS-1131
GUDID 05391529585150
Apex Tibial Nailing System Case
ORTHOXEL DESIGNATED ACTIVITY COMPANY
Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable| Primary Device ID | 05391529585150 |
| NIH Device Record Key | f071d635-5f5a-4b10-be28-bc3c6a494e02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Apex |
| Version Model Number | INS-1131 |
| Catalog Number | INS-1131 |
| Company DUNS | 985596830 |
| Company Name | ORTHOXEL DESIGNATED ACTIVITY COMPANY |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
| Special Storage Condition, Specify | Between 0 and 0 *Ambient Storage and Handling |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391529585150 [Primary] |
FDA Product Code
| LXH | Orthopedic Manual Surgical Instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
[05391529585150]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-08 |
| Device Publish Date | 2021-01-29 |
On-Brand Devices [Apex]
| 05391529580797 | Apex Tibial Endcap |
| 05391529580780 | Apex Tibia Endcap |
| 05391529580773 | Apex Tibial Endcap |
| 05391529580582 | Apex Tibial Nail, Sterile |
| 05391529580193 | Apex Tibia Screw, Sterile |
| 05391529580186 | Apex Tibial Screw, Sterile |
| 05391529580179 | Apex Tibial Screw, Sterile |
| 05391529580162 | Apex Tibial Screw, Sterile |
| 05391529580155 | Apex Tibial Screw, Sterile |
| 05391529580148 | Apex Tibial Screw, Sterile |
| 05391529582180 | Tibial Extraction Bolt |
| 05391529581459 | Tibial Insertion Handle |
| 05391529581237 | Tibial Radiolucent Guide ML |
| 05391529581114 | Tibial Insertion Bolt |
| 05391529585150 | Apex Tibial Nailing System Case |
| 05391529584245 | Yellow Ø4.25mm Drill Sleeve (Length 138.5mm) |
| 05391529584238 | Trocar Ø8.0mm x Length 150.0mm |
| 05391529584221 | Green Outer Drill Sleeve (Length 129mm) |
| 05391529584214 | Suprapatellar AO Mount Anchor Pin |
| 05391529584207 | AO Mount Drill Extension (Length 136.5mm) |
| 05391529584191 | Suprapatellar Trocar |
| 05391529584184 | Suprapatellar K-Wire Guide |
| 05391529584177 | Suprapatellar Standard Protection Sleeve |
| 05391529584160 | Suprapatellar Anchoring Protection Sleeve |
| 05391529584153 | Suprapatellar Protection Sleeve Handle Connector |
| 05391529584146 | Suprapatellar Protection Sleeve Handle |
| 05391529584139 | Tibial Suprapatellar Connecting Bolt |
| 05391529584122 | Tibial Suprapatellar Insert Retainer |
| 05391529584115 | Tibial Infrapatellar Connecting Bolt |
| 05391529584108 | Tibial Infrapatellar Insert Retainer |
| 05391529584092 | Tibial Targeting Guide Locking Bolt |
| 05391529584085 | Tibial Targeting Guide |
| 05391529584078 | Tibial Suprapatellar Insertion Handle |
| 05391529584061 | Tibial Infrapatellar Insertion Handle |
| 05391529584054 | Ø12 Cannulated Curved Awl |
| 05391529583149 | Large AO T-Handle |
| 05391529583125 | Insert Retainer Containing Bolt |
| 05391529583101 | Monobloc Reamer, Size 8.0 |
| 05391529583095 | Yellow Ø4.25mm Twist Drill X Length 300mm (Use Ø5.00mm Locking Screw) |
| 05391529583088 | Monobloc Reamer, Size 7.0 |
| 05391529583071 | Locking Screw Length Gauge (Hook) |
| 05391529583064 | Monobloc Reamer, Size 6.0 |
| 05391529583057 | Flexible IM reamer Shaft 470mm |
| 05391529583040 | Modular Reamer Head, Size 16.0 |
| 05391529583033 | Modular Reamer Head, Size 15.5 |
| 05391529583026 | Modular Reamer Head, Size 15.0 |
| 05391529583019 | Modular Reamer Head, Size 14.5 |
| 05391529583002 | Modular Reamer Head, Size 14.0 |
| 05391529582999 | Modular Reamer Head, Size 13.5 |
| 05391529582982 | Modular Reamer Head, Size 13.0 |
Trademark Results [Apex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 APEX 98551489 not registered Live/Pending |
Ace Bayou Corp. 2024-05-15 |
 APEX 98549869 not registered Live/Pending |
Cizion LLC 2024-05-14 |
 APEX 98545741 not registered Live/Pending |
AFTERMARKET PERFORMANCE EXPRESS 2024-05-11 |
 APEX 98529513 not registered Live/Pending |
Corey Oil, Ltd. 2024-05-01 |
 APEX 98509132 not registered Live/Pending |
HP Tuners LLC 2024-04-19 |
 APEX 98490269 not registered Live/Pending |
Wilson, Randi 2024-04-09 |
APEX 98490269 not registered Live/Pending |
Huckabee, Dayna 2024-04-09 |
 APEX 98482256 not registered Live/Pending |
Hubbell Incorporated 2024-04-03 |
 APEX 98479576 not registered Live/Pending |
Apex Technology, Inc. 2024-04-02 |
 APEX 98479573 not registered Live/Pending |
Apex Technology, Inc. 2024-04-02 |
 APEX 98457746 not registered Live/Pending |
S. Rays, Inc. 2024-03-19 |
 APEX 98447337 not registered Live/Pending |
Rekluse Racing, LLC 2024-03-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.