ALPHATEC SOLUS
GUDID 00844856099173
ALPHATEC SOLUS LUMBAR SPACER, 18mm LARGE, 12 LORDOTIC, STERILE
ALPHATEC SPINE, INC.
Polymeric spinal fusion cage, sterile Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage| Primary Device ID | 00844856099173 |
| NIH Device Record Key | 6f69650c-d07d-478e-b156-71043e033c8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALPHATEC SOLUS |
| Version Model Number | 25600-318-S |
| 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 | true |
| 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
| Height | 18 Millimeter |
| Height | 18 Millimeter |
| Angle | 12 degree |
| Height | 18 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844856099173 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123993
FDA Product Code
| OVD | Intervertebral fusion device with integrated fixation, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00844856099173]
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Radiation Sterilization
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Radiation Sterilization
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Radiation Sterilization
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[00844856099173]
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[00844856099173]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-08-31 |
On-Brand Devices [ALPHATEC SOLUS]
| 00844856099173 | ALPHATEC SOLUS LUMBAR SPACER, 18mm LARGE, 12 LORDOTIC, STERILE |
| 00844856099166 | ALPHATEC SOLUS LUMBAR SPACER, 16mm LARGE, 12 LORDOTIC, STERILE |
| 00844856099159 | ALPHATEC SOLUS LUMBAR SPACER, 14mm LARGE, 12 LORDOTIC, STERILE |
| 00844856099142 | ALPHATEC SOLUS LUMBAR SPACER, 12mm LARGE, 12 LORDOTIC, STERILE |
| 00844856099135 | ALPHATEC SOLUS LUMBAR SPACER, 18mm LARGE, 7 LORDOTIC, STERILE |
| 00844856099128 | ALPHATEC SOLUS LUMBAR SPACER, 16mm LARGE, 7 LORDOTIC, STERILE |
| 00844856099111 | ALPHATEC SOLUS LUMBAR SPACER, 14mm LARGE, 7 LORDOTIC, STERILE |
| 00844856099104 | ALPHATEC SOLUS LUMBAR SPACER, 12mm LARGE, 7 LORDOTIC, STERILE |
| 00844856099098 | ALPHATEC SOLUS LUMBAR SPACER, 10mm LARGE, 7 LORDOTIC, STERILE |
| 00844856099081 | ALPHATEC SOLUS LUMBAR SPACER, 16mm MEDIUM, 12 LORDOTIC, STERILE |
| 00844856099074 | ALPHATEC SOLUS LUMBAR SPACER, 14mm MEDIUM, 12 LORDOTIC, STERILE |
| 00844856099067 | ALPHATEC SOLUS LUMBAR SPACER, 12mm MEDIUM, 12 LORDOTIC, STERILE |
| 00844856099050 | ALPHATEC SOLUS LUMBAR SPACER, 16mm MEDIUM, 7 LORDOTIC, STERILE |
| 00844856099043 | ALPHATEC SOLUS LUMBAR SPACER, 14mm MEDIUM, 7 LORDOTIC, STERILE |
| 00844856099036 | ALPHATEC SOLUS LUMBAR SPACER, 12mm MEDIUM, 7 LORDOTIC, STERILE |
| 00844856099029 | ALPHATEC SOLUS LUMBAR SPACER, 10mm MEDIUM, 7 LORDOTIC, STERILE |
| 00844856062719 | ALPHATEC SOLUS DISTAL WRENCH TIP |
| 00844856054387 | Solus Lumbar Inserter / Distractor |
| 00840967190525 | Solus Distal Deployment Wrench |
| 00840967190488 | Solus Straight Inserter |
| 00840967190464 | Solus, Lumbar Trial, Large, 18 mm, 12° Lordotic, Body |
| 00840967190457 | Solus, Lumbar Trial, Large, 16 mm, 12° Lordotic, Body |
| 00840967190440 | Solus, Lumbar Trial, Large, 14 mm, 12° Lordotic, Body |
| 00840967190433 | Solus, Lumbar Trial, Large, 12 mm, 12° Lordotic, Body |
| 00840967190426 | Solus, Lumbar Trial, Large, 18 mm, 7° Lordotic, Body |
| 00840967190419 | Solus, Lumbar Trial, Large, 16 mm, 7° Lordotic, Body |
| 00840967190402 | Solus, Lumbar Trial, Large, 14 mm, 7° Lordotic, Body |
| 00840967190396 | Solus, Lumbar Trial, Large, 12 mm, 7° Lordotic, Body |
| 00840967190389 | Solus, Lumbar Trial, Large, 10 mm, 7° Lordotic, Body |
| 00840967190372 | Solus, Lumbar Trial, Medium, 16 mm, 12° Lordotic, Body |
| 00840967190365 | Solus, Lumbar Trial, Medium, 14 mm, 12° Lordotic, Body |
| 00840967190358 | Solus, Lumbar Trial, Medium, 12 mm, 12° Lordotic, Body |
| 00840967190341 | Solus, Lumbar Trial, Medium, 16 mm, 7° Lordotic, Body |
| 00840967190334 | Solus, Lumbar Trial, Medium, 14 mm, 7° Lordotic, Body |
| 00840967190327 | Solus, Lumbar Trial, Medium, 12 mm, 7° Lordotic, Body |
| 00840967190310 | Solus, Lumbar Trial, Medium, 10 mm, 7° Lordotic, Body |
| 00840967189239 | Solus Proximal Deployment Wrench |
Trademark Results [ALPHATEC SOLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALPHATEC SOLUS 85365190 4187920 Live/Registered |
Alphatec Spine, Inc. 2011-07-07 |
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