Primary Device ID | 00844856026971 |
NIH Device Record Key | 22541631-7cf4-4f9c-9f2c-55403e68dfbc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Solanas |
Version Model Number | 63933 |
Company DUNS | 602465783 |
Company Name | ALPHATEC SPINE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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(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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00844856026971 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
[00844856026971]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2024-09-11 |
Device Publish Date | 2020-06-17 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOLANAS 77181251 3391172 Live/Registered |
Alphatec Spine, Inc. 2007-05-15 |