SynCage 08825366S
GUDID H98108825366S0
SYNCAGE EVOLUTION SPACER-LARGE 19MM HEIGHT/18DEG-STERILE
SYNTHES (U.S.A.) LP
Polymeric spinal interbody fusion cage| Primary Device ID | H98108825366S0 |
| NIH Device Record Key | d53cf548-9800-4244-ab9c-fc2573dad905 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SynCage |
| Version Model Number | 08.825.366S |
| Catalog Number | 08825366S |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| Device Count | 1 |
| DM Exempt | false |
| 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
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034760735 [Primary] |
| HIBCC | H98108825366S0 [Secondary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K122639
FDA Product Code
| MAX | Intervertebral fusion device with bone graft, lumbar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
[H98108825366S0]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-09-04 |
| Device Publish Date | 2015-09-14 |
On-Brand Devices [SynCage]
| 07611819220836 | SYNCAGE IMPLANT HOLDER- OFFSET |
| 07611819220829 | SYNCAGE IMPLANT HOLDER- STRAIGHT |
| H98108825265S0 | SYNCAGE EVOLUTION SPACER-MED 17MM HEIGHT/18DEG-STERILE |
| H98108825264S0 | SYNCAGE EVOLUTION SPACER-MED 15MM HEIGHT/18DEG-STERILE |
| H98108825263S0 | SYNCAGE EVOLUTION SPACER-MED 13.5MM HEIGHT/18DEG-STERILE |
| H98108825226S0 | SYNCAGE EVOLUTION SPACER-MED 19MM HEIGHT/14DEG-STERILE |
| H98108825225S0 | SYNCAGE EVOLUTION SPACER-MED 17MM HEIGHT/14DEG-STERILE |
| H98108825224S0 | SYNCAGE EVOLUTION SPACER-MED 15MM HEIGHT/14DEG-STERILE |
| H98108825223S0 | SYNCAGE EVOLUTION SPACER-MED 13.5MM HEIGHT/14DEG-STERILE |
| H98108825222S0 | SYNCAGE EVOLUTION SPACER-MED 12MM HEIGHT/14DEG-STERILE |
| H98108825216S0 | SYNCAGE EVOLUTION SPACER-MED 19MM HEIGHT/10DEG-STERILE |
| H98108825215S0 | SYNCAGE EVOLUTION SPACER-MED 17MM HEIGHT/10DEG-STERILE |
| H98108825214S0 | SYNCAGE EVOLUTION SPACER-MED 15MM HEIGHT/10DEG-STERILE |
| H98108825213S0 | SYNCAGE EVOLUTION SPACER-MED 13.5MM HEIGHT/10DEG-STERILE |
| H98108825212S0 | SYNCAGE EVOLUTION SPACER-MED 12MM HEIGHT/10DEG-STERILE |
| H98108825211S0 | SYNCAGE EVOLUTION SPACER-MED 10.5MM HEIGHT/10DEG-STERILE |
| H98108825206S0 | SYNCAGE EVOLUTION SPACER-MED 19MM HEIGHT/6DEG-STERILE |
| H98108825205S0 | SYNCAGE EVOLUTION SPACER-MED 17MM HEIGHT/6DEG-STERILE |
| H98108825204S0 | SYNCAGE EVOLUTION SPACER-MED 15MM HEIGHT/6DEG-STERILE |
| H98108825203S0 | SYNCAGE EVOLUTION SPACER-MED 13.5MM HEIGHT/6DEG-STERILE |
| H98108825202S0 | SYNCAGE EVOLUTION SPACER-MED 12MM HEIGHT/6DEG-STERILE |
| H98108825201S0 | SYNCAGE EVOLUTION SPACER-MED 10.5MM HEIGHT/6DEG-STERILE |
| H98108825200S0 | SYNCAGE EVOLUTION SPACER-MED 9MM HEIGHT/6DEG-STERILE |
| H98108825366S0 | SYNCAGE EVOLUTION SPACER-LARGE 19MM HEIGHT/18DEG-STERILE |
| H98108825365S0 | SYNCAGE EVOLUTION SPACER-LARGE 17MM HEIGHT/18DEG-STERILE |
| H98108825364S0 | SYNCAGE EVOLUTION SPACER-LARGE 15MM HEIGHT/18DEG-STERILE |
| H98108825363S0 | SYNCAGE EVOLUTION SPACER-LARGE 13.5MM HEIGHT/18DEG-STERILE |
| H98108825326S0 | SYNCAGE EVOLUTION SPACER-LARGE 19MM HEIGHT/14DEG-STERILE |
| H98108825325S0 | SYNCAGE EVOLUTION SPACER-LARGE 17MM HEIGHT/14DEG-STERILE |
| H98108825324S0 | SYNCAGE EVOLUTION SPACER-LARGE 15MM HEIGHT/14DEG-STERILE |
| H98108825323S0 | SYNCAGE EVOLUTION SPACER-LARGE 13.5MM HEIGHT/14DEG-STERILE |
| H98108825322S0 | SYNCAGE EVOLUTION SPACER-LARGE 12MM HEIGHT/14DEG-STERILE |
| H98108825316S0 | SYNCAGE EVOLUTION SPACER-LARGE 19MM HEIGHT/10DEG-STERILE |
| H98108825315S0 | SYNCAGE EVOLUTION SPACER-LARGE 17MM HEIGHT/10DEG-STERILE |
| H98108825314S0 | SYNCAGE EVOLUTION SPACER-LARGE 15MM HEIGHT/10DEG-STERILE |
| H98108825313S0 | SYNCAGE EVOLUTION SPACER-LARGE 13.5MM HEIGHT/10DEG-STERILE |
| H98108825312S0 | SYNCAGE EVOLUTION SPACER-LARGE 12MM HEIGHT/10DEG-STERILE |
| H98108825311S0 | SYNCAGE EVOLUTION SPACER-LARGE 10.5MM HEIGHT/10DEG-STERILE |
| H98108825306S0 | SYNCAGE EVOLUTION SPACER-LARGE 19MM HEIGHT/6DEG-STERILE |
| H98108825305S0 | SYNCAGE EVOLUTION SPACER-LARGE 17MM HEIGHT/6DEG-STERILE |
| H98108825304S0 | SYNCAGE EVOLUTION SPACER-LARGE 15MM HEIGHT/6DEG-STERILE |
| H98108825302S0 | SYNCAGE EVOLUTION SPACER-LARGE 12MM HEIGHT/6DEG-STERILE |
| H98108825301S0 | SYNCAGE EVOLUTION SPACER-LARGE 10.5MM HEIGHT/6DEG-STERILE |
| H98108825300S0 | SYNCAGE EVOLUTION SPACER-LARGE 9MM HEIGHT/6DEG-STERILE |
| H98108825266S0 | SYNCAGE EVOLUTION SPACER-MED 19MM HEIGHT/18DEG-STERILE |
| H98108825166S0 | SYNCAGE EVOLUTION SPACER-SMALL 19MM HEIGHT/18DEG-STERILE |
| H98108825165S0 | SYNCAGE EVOLUTION SPACER-SMALL 17MM HEIGHT/18DEG-STERILE |
| H98108825164S0 | SYNCAGE EVOLUTION SPACER-SMALL 15MM HEIGHT/18DEG-STERILE |
| H98108825163S0 | SYNCAGE EVOLUTION SPACER-SMALL 13.5MM HEIGHT/18DEG-STERILE |
| H98108825126S0 | SYNCAGE EVOLUTION SPACER-SMALL 19MM HEIGHT/14DEG-STERILE |
Trademark Results [SynCage]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYNCAGE 75591902 2304189 Live/Registered |
DEPUY SYNTHES, INC. 1998-11-19 |
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