| Primary Device ID | 00190376206011 |
| NIH Device Record Key | 431b9a06-f681-436b-b9d9-89742d0ee562 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMP |
| Version Model Number | 116-4-6050 |
| 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 |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 50 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376206011 [Primary] |
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
[00190376206011]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-20 |
| Device Publish Date | 2020-01-10 |
| 00190376206288 | LIF AMP, TWO SCREW PLATE, 05 |
| 00190376206271 | LIF AMP, TWO SCREW PLATE, 04 |
| 00190376206264 | LIF AMP, ONE SCREW PLATE, 16 |
| 00190376206257 | LIF AMP, ONE SCREW PLATE, 15 |
| 00190376206240 | LIF AMP, ONE SCREW PLATE, 14 |
| 00190376206233 | LIF AMP, ONE SCREW PLATE, 13 |
| 00190376206226 | LIF AMP, ONE SCREW PLATE, 12 |
| 00190376206219 | LIF AMP, ONE SCREW PLATE, 11 |
| 00190376206202 | LIF AMP, ONE SCREW PLATE, 10 |
| 00190376206196 | LIF AMP, ONE SCREW PLATE, 09 |
| 00190376206189 | LIF AMP, ONE SCREW PLATE, 08 |
| 00190376206172 | LIF AMP, ONE SCREW PLATE, 07 |
| 00190376206165 | LIF AMP, ONE SCREW PLATE, 06 |
| 00190376206158 | LIF AMP, ONE SCREW PLATE, 05 |
| 00190376206141 | LIF AMP, ONE SCREW PLATE, 04 |
| 00190376206134 | LIF AMP, Ø6.5mm x 65mm BONE SCREW |
| 00190376206127 | LIF AMP, Ø6.5mm x 60mm BONE SCREW |
| 00190376206110 | LIF AMP, Ø6.5mm x 55mm BONE SCREW |
| 00190376206103 | LIF AMP, Ø6.5mm x 50mm BONE SCREW |
| 00190376206097 | LIF AMP, Ø6.5mm x 45mm BONE SCREW |
| 00190376206080 | LIF AMP, Ø6.5mm x 40mm BONE SCREW |
| 00190376206073 | LIF AMP, Ø6.5mm x 35mm BONE SCREW |
| 00190376206066 | LIF AMP, Ø6.5mm x 30mm BONE SCREW |
| 00190376206059 | LIF AMP, Ø6.5mm x 25mm BONE SCREW |
| 00190376206042 | LIF AMP, Ø6.0mm x 65mm BONE SCREW |
| 00190376206035 | LIF AMP, Ø6mm x 60mm BONE SCREW |
| 00190376206028 | LIF AMP, Ø6mm x 55mm BONE SCREW |
| 00190376206011 | LIF AMP, Ø6mm x 50mm BONE SCREW |
| 00190376206004 | LIF AMP, Ø6mm x 45mm BONE SCREW |
| 00190376205991 | LIF AMP, Ø6mm x 40mm BONE SCREW |
| 00190376205984 | LIF AMP, Ø6mm x 35mm BONE SCREW |
| 00190376205977 | LIF AMP, Ø6mm x 30mm BONE SCREW |
| 00190376205960 | LIF AMP, Ø6mm x 25mm BONE SCREW |
| 00190376205953 | LIF AMP, Ø5.5mm x 65mm BONE SCREW |
| 00190376205946 | LIF AMP, Ø5.5mm x 60mm BONE SCREW |
| 00190376205939 | LIF AMP, Ø5.5mm x 55mm BONE SCREW |
| 00190376205922 | LIF AMP, Ø5.5mm x 50mm BONE SCREW |
| 00190376205915 | LIF AMP, Ø5.5mm x 45mm BONE SCREW |
| 00190376205908 | LIF AMP, Ø5.5mm x 40mm BONE SCREW |
| 00190376205892 | LIF AMP, Ø5.5mm x 35mm BONE SCREW |
| 00190376205885 | LIF AMP, Ø5.5mm x 30mm BONE SCREW |
| 00190376205878 | LIF AMP, Ø5.5mm x 25mm BONE SCREW |
| 00190376205861 | LIF AMP, CENTER SCREW, 20mm |
| 00190376205854 | LIF AMP, CENTER SCREW, 17.5mm |
| 00190376205847 | LIF AMP, CENTER SCREW, 15mm |
| 00190376205830 | LIF AMP, CENTER SCREW, 12.5mm |
| 00190376205823 | LIF AMP, CENTER SCREW, 10mm |
| 00190376205816 | LIF AMP, TWO SCREW PLATE, 16 |
| 00190376205809 | LIF AMP, TWO SCREW PLATE, 15 |
| 00190376205793 | LIF AMP, TWO SCREW PLATE, 14 |