Solanas
GUDID 00844856007147
POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 28mm
ALPHATEC SPINE, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00844856007147 |
| NIH Device Record Key | 972bb98e-1417-4887-ba81-ebd33614ab06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solanas |
| Version Model Number | 63043-28 |
| 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 | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
| Outer Diameter | 4.35 Millimeter |
| Length | 28 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844856007147 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K173522
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
[00844856007147]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-01 |
| Device Publish Date | 2020-06-23 |
On-Brand Devices [Solanas]
| 00844856007185 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 44mm |
| 00844856007178 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 40mm |
| 00844856007161 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 36mm |
| 00844856007147 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 28mm |
| 00844856007130 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 24mm |
| 00844856007123 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 20mm |
| 00844856007116 | POLYAXIAL POSTERIOR THORACIC SCREW, Ø4.35mm X 16mm |
| 00844856007697 | 3.0mm ROD TEMPLATE, 15cm |
| 00190376276274 | SOLANAS REV 3 IMPLANTS AND INSTRUMENTS |
| 00844856007543 | CERVICAL HOOK HOLDER |
| 00844856007536 | CERVICAL HOOK TRIAL |
| 00844856000049 | SMALL DEPTH GAUGE 2.7/4.0 |
| 00844856007581 | THORACIC SCREW BONE AWL |
| 00844856026933 | THORACIC TAP, 4.35mm |
| 00844856026926 | THORACIC TAP, 3.0mm |
| 00844856007512 | THORACIC TAP, 4.0mm |
| 00844856007505 | THORACIC TAP, 3.5mm |
| 00844856007901 | ADJUSTABLE DRILL SLEEVE |
| 00844856051973 | SET SCREW INSERTER-HL-R |
| 00844856051959 | THORACIC SCREW HEAD POSITIONER |
| 00844856043459 | HEX SET SCREW REMOVAL TOOL |
| 00844856026971 | CERVICAL HOOK IMPACTER |
| 00840967191256 | SELF RETAINING SET SCREW INSERTER |
Trademark Results [Solanas]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOLANAS 77181251 3391172 Live/Registered |
Alphatec Spine, Inc. 2007-05-15 |
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