Calibrate
GUDID 00190376473970
LTX HL SPACER, 6 x 22 x 55 mm, 30°
ALPHATEC SPINE, INC.
Metallic spinal interbody fusion cage| Primary Device ID | 00190376473970 |
| NIH Device Record Key | 6dff1ae1-10d6-4448-8e4e-69baac93ea62 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calibrate |
| Version Model Number | 257-06225530 |
| Company DUNS | 602465783 |
| Company Name | ALPHATEC SPINE, INC. |
| 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 | 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
Device Dimensions
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
| Length | 55 Millimeter |
| Width | 22 Millimeter |
| Angle | 30 degree |
| Height | 6 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376473970 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K222455
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
[00190376473970]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-30 |
| Device Publish Date | 2023-03-22 |
On-Brand Devices [Calibrate]
| 00190376474786 | LTX REMOVAL TOOL |
| 00190376474779 | LTX EXPANSION DRIVER AXIAL, 26 in-lbs |
| 00190376474762 | LTX EXPANSION DRIVER T-HANDLE, 26 in-lbs |
| 00190376474205 | LTX TRIAL, 6 x 22 x 60 mm, 20° |
| 00190376474199 | LTX TRIAL, 6 x 22 x 60 mm, 15° |
| 00190376473994 | LTX SPACER, 6 x 22 x 60 mm, 20° |
| 00190376473987 | LTX SPACER, 6 x 22 x 60 mm, 15° |
| 00190376473963 | LTX SPACER, 6 x 22 x 55 mm, 20° |
| 00190376473956 | LTX SPACER, 6 x 22 x 55 mm, 15° |
| 00190376473932 | LTX SPACER, 6 x 22 x 50 mm, 20° |
| 00190376473925 | LTX SPACER, 6 x 22 x 50 mm, 15° |
| 00190376473901 | LTX SPACER, 6 x 22 x 45 mm, 20° |
| 00190376473895 | LTX SPACER, 6 x 22 x 45 mm, 15° |
| 00190376473888 | LTX SPACER, 6 x 18 x 60 mm, 20° |
| 00190376473871 | LTX SPACER, 6 x 18 x 60 mm, 15° |
| 00190376473864 | LTX SPACER, 6 x 18 x 55 mm, 20° |
| 00190376473857 | LTX SPACER, 6 x 18 x 55 mm, 15° |
| 00190376473840 | LTX SPACER, 6 x 18 x 50 mm, 20° |
| 00190376473833 | LTX SPACER, 6 x 18 x 50 mm, 15° |
| 00190376473826 | LTX SPACER, 6 x 18 x 45 mm, 20° |
| 00190376473819 | LTX SPACER, 6 x 18 x 45 mm, 15° |
| 00190376472218 | LTX GRAFT TUBE |
| 00190376472201 | LTX GRAFT TAMP |
| 00190376472195 | LTX GRAFT FUNNEL |
| 00190376472164 | LTX ATTACHMENT DRIVER |
| 00190376472157 | LTX Freehand Expansion Driver |
| 00190376472140 | LTX ANGLED INSERTER, OFFSET LEFT |
| 00190376472133 | LTX ANGLED INSERTER, OFFSET RIGHT |
| 00190376472089 | LTX INSERTER |
| 00190376472072 | LTX TRIAL, 6 x 22 x 60 mm, 30° |
| 00190376472065 | LTX TRIAL, 6 x 18 x 60 mm, 20° |
| 00190376472058 | LTX TRIAL, 6 x 18 x 60 mm, 15° |
| 00190376474182 | LTX Bone Screw, Ø5.5 mm x 60 mm |
| 00190376474175 | LTX Bone Screw, Ø5.5 mm x 55 mm |
| 00190376474168 | LTX Bone Screw, Ø5.5 mm x 50 mm |
| 00190376474151 | LTX Bone Screw, Ø5.5 mm x 45 mm |
| 00190376474144 | LTX Bone Screw, Ø5.5 mm x 40 mm |
| 00190376474137 | LTX Bone Screw, Ø5.5 mm x 35 mm |
| 00190376474120 | LTX Bone Screw, Ø5.5 mm x 30 mm |
| 00190376474113 | LTX Bone Screw, Ø5.5 mm x 25 mm |
| 00190376474106 | LTX Bone Screw, Ø5.0 mm x 60 mm |
| 00190376474090 | LTX Bone Screw, Ø5.0 mm x 55 mm |
| 00190376474083 | LTX Bone Screw, Ø5.0 mm x 50 mm |
| 00190376474076 | LTX Bone Screw, Ø5.0 mm x 45 mm |
| 00190376474069 | LTX Bone Screw, Ø5.0 mm x 40 mm |
| 00190376474052 | LTX Bone Screw, Ø5.0 mm x 35 mm |
| 00190376474045 | LTX Bone Screw, Ø5.0 mm x 30 mm |
| 00190376474038 | LTX Bone Screw, Ø5.0 mm x 25 mm |
| 00190376474007 | LTX HL SPACER, 6 x 22 x 60 mm, 30° |
| 00190376473970 | LTX HL SPACER, 6 x 22 x 55 mm, 30° |
Trademark Results [Calibrate]
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