SynCage 08825324S
GUDID H98108825324S0
SYNCAGE EVOLUTION SPACER-LARGE 15MM HEIGHT/14DEG-STERILE
SYNTHES (U.S.A.) LP
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 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 | H98108825324S0 |
| NIH Device Record Key | cdf92f4c-a519-467b-99b0-2b6b4f5ba705 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SynCage |
| Version Model Number | 08.825.324S |
| Catalog Number | 08825324S |
| 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 | 10705034760674 [Primary] |
| HIBCC | H98108825324S0 [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 |
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
Moist Heat or Steam Sterilization
[H98108825324S0]
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.