| Primary Device ID | 10888857553033 |
| NIH Device Record Key | f9db8cf3-0a6b-4a5f-b44a-671d2d978a2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Q Pedicle Instruments |
| Version Model Number | 48111003 |
| Catalog Number | 48111003 |
| Company DUNS | 146060863 |
| Company Name | K2M, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | 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 |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 |
| mark.zellers@stryker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857553033 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
[10888857553033]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-26 |
| Device Publish Date | 2024-08-16 |
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| 10888857553439 | ES2 Q Tap, Cannulated Ø8.5mm |
| 10888857553422 | ES2 Q Tap, Cannulated Ø7.5mm |
| 10888857553415 | ES2 Q Tap, Cannulated Ø6.5mm |
| 10888857553408 | ES2 Q Tap, Cannulated Ø5.5mm |
| 10888857553392 | ES2 Q Tap, Cannulated Ø4.5mm |
| 10888857553385 | Everest MI XT Q Tap, Cannulated Ø8.5mm |
| 10888857553378 | Everest MI XT Q Tap, Cannulated Ø7.5mm |
| 10888857553361 | Everest MI XT Q Tap, Cannulated Ø6.5mm |
| 10888857553354 | Everest MI XT Q Tap, Cannulated Ø5.5mm |
| 10888857553347 | Everest MI XT Q Tap, Cannulated Ø4.5mm |
| 10888857553224 | Q Screwdriver Spin Sleeve |
| 10888857553200 | Q Driver and Probes Instruments Tray |
| 10888857553187 | Q General Navigation Instruments Tray |
| 10888857553170 | Q Power Handpiece Instruments Tray |
| 10888857553163 | Q Signature Instruments Tray |
| 10888857553088 | Q Navigation Adaptor Calibration Tool |
| 10888857553064 | Q Ratchet Round Handle |
| 10888857553040 | Q Gear Shift Handle |
| 10888857553033 | Q Awl |
| 10888857553026 | Q Lumbar Probe |
| 10888857553019 | Q Thoracic Probe |
| 10888857553002 | Q Drill Stop |
| 10888857552999 | Q Drill - Small Ø2.5mm |
| 10888857552982 | Q Drill - Small Ø3.5mm |
| 10888857552975 | Q Drill - Small Ø4.0mm |
| 10888857552968 | Q Drill - Small Ø4.5mm |
| 10888857552951 | Q Drill - Small Ø5.0mm |
| 10888857552944 | Q Ratchet T-Handle |
| 10888857552937 | Q Drill - Large Ø5.0mm |
| 10888857552920 | Q Drill - Large Ø6.5mm |
| 10888857552913 | Q Drill - Large Ø7.5mm |
| 10888857552845 | Xia 3 Q Tap Ø10.5mm |
| 10888857552838 | Xia 3 Q Tap Ø3.0mm |
| 10888857552821 | Xia 3 Q Tap Ø3.5mm |
| 10888857552814 | Xia 3 Q Tap Ø4.0mm |
| 10888857552807 | Xia 3 Q Tap Ø4.5mm |
| 10888857552791 | Xia 3 Q Tap Ø5.0mm |
| 10888857552784 | Xia 3 Q Tap Ø5.5mm |
| 10888857552777 | Xia 3 Q Tap Ø6.5mm |
| 10888857552760 | Xia 3 Q Tap Ø7.5mm |
| 10888857552753 | Xia 3 Q Tap Ø8.5mm |
| 10888857552746 | Xia 3 Q Tap Ø9.5mm |
| 10888857552739 | Everest Q Tap Ø10.5mm |
| 10888857552722 | Everest Q Tap Ø3.5mm |
| 10888857552715 | Everest Q Tap Ø4.5mm |
| 10888857552708 | Everest Q Tap Ø5.5mm |
| 10888857552692 | Everest Q Tap Ø6.5mm |
| 10888857552685 | Everest Q Tap Ø7.5mm |
| 10888857552678 | Everest Q Tap Ø8.5mm |