ALPHATEC SOLUS
GUDID 00844856099029
ALPHATEC SOLUS LUMBAR SPACER, 10mm MEDIUM, 7 LORDOTIC, STERILE
ALPHATEC SPINE, INC.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00844856099029 |
| NIH Device Record Key | 55e6b5e5-88ae-48c7-971d-5724cdf637bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALPHATEC SOLUS |
| Version Model Number | 25200-110-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 | 10 Millimeter |
| Height | 10 Millimeter |
| Angle | 7 degree |
| Height | 10 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844856099029 [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 |
[00844856099029]
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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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