OsseoScrew
GUDID 00844856049048
OSSEOSCREW F TI HIGH TOP 6.5 X 40MM
ALPHATEC SPINE, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00844856049048 |
| NIH Device Record Key | a3814748-7ff8-4528-b209-5fd881ea42ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsseoScrew |
| Version Model Number | 53165-40 |
| 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
| Outer Diameter | 6.5 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844856049048 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K181980
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
[00844856049048]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-07 |
| Device Publish Date | 2019-12-30 |
On-Brand Devices [OsseoScrew]
| 00844856051713 | OSSEOSCREW DEPLOYMENT T-HANDLE |
| 00844856051706 | OSSEOSCREW UN-DEPLOY TOOL |
| 00844856051683 | OSSEOSCREW POLYAXIAL/HIGH TOP DRIVER |
| 00844856051676 | Osseoscrew Deployment Shaft, 40 mm |
| 00844856051669 | Osseoscrew Deployment Shaft, 45 mm |
| 00844856051652 | Osseoscrew Deployment Shaft, 50 mm |
| 00844856051645 | Osseoscrew Deployment Shaft, 55 mm |
| 00844856051638 | OSSEOSCREW TRIAL PROBE, RIGHT |
| 00844856051621 | OSSEOSCREW TRIAL PROBE, LEFT |
| 00844856051584 | OSSEOSCREW RETRIEVAL TOOL |
| 00844856049192 | OSSEOSCREW F TI POLYAXIAL 7.5 X 55MM |
| 00844856049185 | OSSEOSCREW F TI POLYAXIAL 7.5 X 50MM |
| 00844856049178 | OSSEOSCREW F TI POLYAXIAL 7.5 X 45MM |
| 00844856049161 | OSSEOSCREW F TI POLYAXIAL 7.5 X 40MM |
| 00844856049154 | OSSEOSCREW F TI POLYAXIAL 6.5 X 55MM |
| 00844856049147 | OSSEOSCREW F TI POLYAXIAL 6.5 X 50MM |
| 00844856049130 | OSSEOSCREW F TI POLYAXIAL 6.5 X 45MM |
| 00844856049123 | OSSEOSCREW F TI POLYAXIAL 6.5 X 40MM |
| 00844856049116 | OSSEOSCREW F TI HIGH TOP 7.5 X 55MM |
| 00844856049109 | OSSEOSCREW F TI HIGH TOP 7.5 X 50MM |
| 00844856049093 | OSSEOSCREW F TI HIGH TOP 7.5 X 45MM |
| 00844856049086 | OSSEOSCREW F TI HIGH TOP 7.5 X 40MM |
| 00844856049079 | OSSEOSCREW F TI HIGH TOP 6.5 X 55MM |
| 00844856049062 | OSSEOSCREW F TI HIGH TOP 6.5 X 50MM |
| 00844856049055 | OSSEOSCREW F TI HIGH TOP 6.5 X 45MM |
| 00844856049048 | OSSEOSCREW F TI HIGH TOP 6.5 X 40MM |
| 00844856044685 | Cannulated Anti-torque Standard/Hightop |
| 00844856036406 | Set Screw Driver |
| 00844856032255 | T-Handle Torque Wrench 100 In-Lbs |
| 00844856026438 | 7.5mm Solid Tapered Polyaxial Tap |
| 00844856026414 | 6.5mm Solid Tapered Polyaxial Tap |
| 00844856026391 | 5.5mm Solid Tapered Polyaxial Tap |
| 00190376073095 | OSSEOSCREW INSERTER INSTRUMENT |
| 00844856051690 | Osseoscrew Inserter Instrument |
| 00190376276151 | OSSEOSCREW INSTRUMENT SET |
| 00190376276144 | OSSEOSCREW IMPLANT SET |
Trademark Results [OsseoScrew]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSEOSCREW 87816924 5814447 Live/Registered |
Alphatec Spine, Inc. 2018-03-01 |
 OSSEOSCREW 85364623 4102102 Dead/Cancelled |
Alphatec Spine, Inc. 2011-07-06 |
 OSSEOSCREW 77442244 3981839 Live/Registered |
Alphatec Spine, Inc. 2008-04-07 |
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