KHEIRON 24SR55045
GUDID 03701313000196
Ø5.5 L45mm straight Ti rod
S.M.A.I.O
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 03701313000196 |
| NIH Device Record Key | 59238c3b-feeb-4a0c-8874-c6c4c8c8a468 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KHEIRON |
| Version Model Number | 24SR55045 |
| Catalog Number | 24SR55045 |
| Company DUNS | 260585710 |
| Company Name | S.M.A.I.O |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com | |
| Phone | +33469842302 |
| contact@smaio.com |
Device Dimensions
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
| Outer Diameter | 5.5 Millimeter |
| Length | 45 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701313000196 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201659
FDA Product Code
| NKB | Thoracolumbosacral Pedicle Screw System |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
[03701313000196]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-21 |
| Device Publish Date | 2020-12-11 |
On-Brand Devices [KHEIRON]
| 03701313001230 | Ø8.5 L60mm pedicle screw |
| 03701313001223 | Ø8.5 L55mm pedicle screw |
| 03701313001216 | Ø8.5 L50mm pedicle screw |
| 03701313001209 | Ø8.5 L45mm pedicle screw |
| 03701313001193 | Ø8.5 L40mm pedicle screw |
| 03701313001186 | Ø8.5 L35mm pedicle screw |
| 03701313001179 | Ø8.5 L30mm pedicle screw |
| 03701313001162 | Ø8.5 L25mm pedicle screw |
| 03701313001087 | Ø7.5 L60mm pedicle screw |
| 03701313001070 | Ø7.5 L55mm pedicle screw |
| 03701313001063 | Ø7.5 L50mm pedicle screw |
| 03701313001056 | Ø7.5 L45mm pedicle screw |
| 03701313001049 | Ø7.5 L40mm pedicle screw |
| 03701313001032 | Ø7.5 L35mm pedicle screw |
| 03701313001025 | Ø7.5 L30mm pedicle screw |
| 03701313001018 | Ø7.5 L25mm pedicle screw |
| 03701313000998 | Ø6.5 L60mm pedicle screw |
| 03701313000981 | Ø6.5 L55mm pedicle screw |
| 03701313000974 | Ø6.5 L50mm pedicle screw |
| 03701313000967 | Ø6.5 L45mm pedicle screw |
| 03701313000950 | Ø6.5 L40mm pedicle screw |
| 03701313000943 | Ø6.5 L35mm pedicle screw |
| 03701313000936 | Ø6.5 L30mm pedicle screw |
| 03701313000929 | Ø6.5 L25mm pedicle screw |
| 03701313000905 | Ø5.5 L60mm pedicle screw |
| 03701313000899 | Ø5.5 L55mm pedicle screw |
| 03701313000882 | Ø5.5 L50mm pedicle screw |
| 03701313000875 | Ø5.5 L45mm pedicle screw |
| 03701313000868 | Ø5.5 L40mm pedicle screw |
| 03701313000851 | Ø5.5 L35mm pedicle screw |
| 03701313000844 | Ø5.5 L30mm pedicle screw |
| 03701313000837 | Ø5.5 L25mm pedicle screw |
| 03701313000813 | Ø4.5 L60mm pedicle screw |
| 03701313000806 | 24PW45055 |
| 03701313000790 | Ø4.5 L50mm pedicle screw |
| 03701313000783 | Ø4.5 L45mm pedicle screw |
| 03701313000776 | Ø4.5 L40mm pedicle screw |
| 03701313000769 | Ø4.5 L35mm pedicle screw |
| 03701313000752 | Ø4.5 L30mm pedicle screw |
| 03701313000745 | Ø4.5 L25mm pedicle screw |
| 03701313000257 | Ø5.5 L95mm straight Ti rod |
| 03701313000240 | Ø5.5 L85mm straight Ti rod |
| 03701313000233 | Ø5.5 L75mm straight Ti rod |
| 03701313000226 | Ø5.5 L65mm straight Ti rod |
| 03701313000219 | Ø5.5 L55mm straight Ti rod |
| 03701313000202 | Ø5.5 L505mm straight Ti rod |
| 03701313000196 | Ø5.5 L45mm straight Ti rod |
| 03701313000189 | Ø5.5 L35mm straight Ti rod |
| 03701313000172 | Ø5.5 L285mm straight Ti rod |
| 03701313000165 | Ø5.5 L185mm straight Ti rod |
Trademark Results [KHEIRON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KHEIRON 79165301 4872495 Live/Registered |
S.M.A.I.O 2015-03-12 |
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