| Primary Device ID | 00190376545493 |
| NIH Device Record Key | 6450a725-8bcf-4203-83c4-a56772e334a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Segmental Plating System |
| Version Model Number | 338-1-13524 |
| 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 |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com | |
| Phone | +1(760)431-9286 |
| Regulatory@alphatecspine.com |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Outer Diameter | 3.5 Millimeter |
| Length | 24 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190376545493 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
[00190376545493]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-08 |
| Device Publish Date | 2024-06-28 |
| 00190376588834 | Segmental Plating System Core Set Configuration |
| 00190376546094 | SPS FA Self-Drill Screw, 3.5 x 19 mm |
| 00190376546087 | SPS FA Self-Drill Screw, 3.5 x 18 mm |
| 00190376546070 | SPS FA Self-Drill Screw, 3.5 x 17 mm |
| 00190376546063 | SPS FA Self-Drill Screw, 3.5 x 16 mm |
| 00190376546056 | SPS FA Self-Drill Screw, 3.5 x 15 mm |
| 00190376546049 | SPS FA Self-Drill Screw, 3.5 x 14 mm |
| 00190376546032 | SPS FA Self-Drill Screw, 3.5 x 13 mm |
| 00190376546025 | SPS FA Self-Drill Screw, 3.5 x 12 mm |
| 00190376546018 | SPS FA Self-Tap Screw, 4.0 x 24 mm |
| 00190376546001 | SPS FA Self-Tap Screw, 4.0 x 23 mm |
| 00190376545998 | SPS FA Self-Tap Screw, 4.0 x 22 mm |
| 00190376545981 | SPS FA Self-Tap Screw, 4.0 x 21 mm |
| 00190376545974 | SPS FA Self-Tap Screw, 4.0 x 20 mm |
| 00190376545967 | SPS FA Self-Tap Screw, 4.0 x 19 mm |
| 00190376545950 | SPS FA Self-Tap Screw, 4.0 x 18 mm |
| 00190376545943 | SPS FA Self-Tap Screw, 4.0 x 17 mm |
| 00190376545936 | SPS FA Self-Tap Screw, 4.0 x 16 mm |
| 00190376545929 | SPS FA Self-Tap Screw, 4.0 x 15 mm |
| 00190376545912 | SPS FA Self-Tap Screw, 4.0 x 14 mm |
| 00190376545905 | SPS FA Self-Tap Screw, 4.0 x 13 mm |
| 00190376545899 | SPS FA Self-Tap Screw, 4.0 x 12 mm |
| 00190376545882 | SPS FA Self-Tap Screw, 3.5 x 24 mm |
| 00190376545875 | SPS FA Self-Tap Screw, 3.5 x 23 mm |
| 00190376545868 | SPS FA Self-Tap Screw, 3.5 x 22 mm |
| 00190376545851 | SPS FA Self-Tap Screw, 3.5 x 21 mm |
| 00190376545844 | SPS FA Self-Tap Screw, 3.5 x 20 mm |
| 00190376545837 | SPS FA Self-Tap Screw, 3.5 x 19 mm |
| 00190376545820 | SPS FA Self-Tap Screw, 3.5 x 18 mm |
| 00190376545813 | SPS FA Self-Tap Screw, 3.5 x 17 mm |
| 00190376545806 | SPS FA Self-Tap Screw, 3.5 x 16 mm |
| 00190376545790 | SPS FA Self-Tap Screw, 3.5 x 15 mm |
| 00190376545783 | SPS FA Self-Tap Screw, 3.5 x 14 mm |
| 00190376545776 | SPS FA Self-Tap Screw, 3.5 x 13 mm |
| 00190376545769 | SPS FA Self-Tap Screw, 3.5 x 12 mm |
| 00190376545752 | SPS VA Self-Drill Screw, 4.0 x 24mm |
| 00190376545745 | SPS VA Self-Drill Screw, 4.0 x 23mm |
| 00190376545738 | SPS VA Self-Drill Screw, 4.0 x 22mm |
| 00190376545721 | SPS VA Self-Drill Screw, 4.0 x 21mm |
| 00190376545714 | SPS VA Self-Drill Screw, 4.0 x 20mm |
| 00190376545707 | SPS VA Self-Drill Screw, 4.0 x 19mm |
| 00190376545691 | SPS VA Self-Drill Screw, 4.0 x 18mm |
| 00190376545684 | SPS VA Self-Drill Screw, 4.0 x 17mm |
| 00190376545677 | SPS VA Self-Drill Screw, 4.0 x 16mm |
| 00190376545660 | SPS VA Self-Drill Screw, 4.0 x 15mm |
| 00190376545653 | SPS VA Self-Drill Screw, 4.0 x 14mm |
| 00190376545646 | SPS VA Self-Drill Screw, 4.0 x 13mm |
| 00190376545639 | SPS VA Self-Drill Screw, 4.0 x 12mm |
| 00190376545622 | SPS VA Self-Tap Screw, 4.0 x 24 mm |
| 00190376545615 | SPS VA Self-Tap Screw, 4.0 x 23 mm |