KyphoPak™ Tray
GUDID 00613994750549
KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
MEDTRONIC SOFAMOR DANEK, INC.
Instrument tray| Primary Device ID | 00613994750549 |
| NIH Device Record Key | 7868c14c-dd4f-452a-b5d5-71cc11664bbd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KyphoPak™ Tray |
| Version Model Number | KPT1504 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994750549 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K041454
FDA Product Code
| HRX | ARTHROSCOPE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-08-09 |
| Device Publish Date | 2016-07-16 |
On-Brand Devices [KyphoPak™ Tray]
| 00613994750549 | KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE |
| 00613994703972 | KIT KPT1502 PAKTRAY 15/3 FF W/OIS-RB |
| 00613994703965 | KIT KPT1505 PAKTRY 15/3 FF W/ONESTEP-RB |
| 00613994703941 | KIT KPT2005 PAKTRY 20/3 FF W/ONE STEP-RB |
| 00613994671721 | CementSys KPT1505-CDS FF XPDR 15/3 1 Stp |
| 00613994668738 | KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS |
| 00613994579843 | CementSys KPT2005-CDS FF XPDR 20/3 1 Stp |
| 00613994579836 | CementSys KPT1505-CDS FF XPDR 15/3 1 Stp |
| 00613994579829 | CementSys KPT1005-CDS FF XPDR 10/3 1 Stp |
| 00643169103139 | KIT KPT1003 KYPAK TRY 10/3 FF W/ADV OIS |
| 00643169102989 | KIT KPT2005 KYPAK TRY 20/3 FF W/ONE STEP |
| 00643169102972 | KIT KPT2004 KYPAK TRY 20/3 ADDL FRACTURE |
| 00643169102965 | KIT KPT2003 KYPAK TRY 20/3 FF W/ADV OIS |
| 00643169102958 | KIT KPT2002 KYPAK TRY 20/3 FF W/OIS |
| 00643169102941 | KIT KPT1505 KYPAK TRY 15/3 FF W/ONESTEP |
| 00643169102934 | KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE |
| 00643169102927 | KIT KPT1503 KYPAK TRY 15/3 FF W/ADV OIS |
| 00643169102910 | KIT KPT1502 KYPAK TRY 15/3 FF W/OIS |
| 00643169102903 | KIT KPT1004 KYPAK TRY 10/3 ADDL FRACTURE |
| 00643169100671 | KIT KPT1001 KYPHOPAK TRAY 10/3 FF W/ITK |
| 00643169100664 | KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS |
| 00643169100657 | CEMENTSYS KPT1002-CDS OIS XPDR 10/3 |
| 00643169100640 | CEMENTSYS KPT1003-CDS AOIS XPDR 10/3 |
| 00643169100633 | KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP |
| 00643169100626 | CEMENTSYS KPT1005-CDS FF XPDR 10/3 1 STP |
| 00643169100619 | KIT KPT1501 KYPHOPAK TRAY 15/3 FF W/ITK |
| 00643169100602 | CEMENTSYS KPT1502-CDS OIS XPDR 15/3 |
| 00643169100596 | CEMENTSYS KPT1503-CDS AOIS XPDR 15/3 |
| 00643169100589 | CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP |
| 00643169100572 | KIT KPT2001 KYPHOPAK TRAY 20/3 FF W/ITK |
| 00643169100565 | CEMENTSYS KPT2002-CDS OIS XPDR 20/3 |
| 00643169100558 | CEMENTSYS KPT2003-CDS AOIS XPDR 20/3 |
| 00643169100541 | CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP |
| 00643169096578 | BONE TAMP KIT KPX103AB FF X2 10/3 AOIS |
| 00643169096554 | BONE TAMP KIT KPX103PB FF X2 10/3 1 STP |
| 00643169096547 | BONE TAMP KIT KPX103RB FF X2 10/3 OIS |
| 00643169096530 | BONE TAMP KIT KPX153AB FF X2 15/3 AOIS |
| 00643169096516 | BONE TAMP KIT KPX153PB FF X2 15/3 1 STP |
| 00643169096509 | BONE TAMP KIT KPX153RB FF X2 15/3 OIS |
| 00643169096493 | BONE TAMP KIT KPX203AB FF X2 20/3 AOIS |
| 00643169096479 | BONE TAMP KIT KPX203PB FF X2 20/3 1 STP |
| 00643169096462 | BONE TAMP KIT KPX203RB FF X2 20/3 OIS |
| 00613994962362 | BONE TAMP KIT KPX203PB FF X2 20/3 1 STP |
| 00613994962348 | BONE TAMP KIT KPX153PB FF X2 15/3 1 STP |
| 00643169456105 | CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP |
| 00643169456099 | CEMENTSYS KPT2003-CDS AOIS XPDR 20/3 |
| 00643169456082 | CEMENTSYS KPT2002-CDS OIS XPDR 20/3 |
| 00643169456075 | CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP |
| 00643169456068 | CEMENTSYS KPT1503-CDS AOIS XPDR 15/3 |
| 00643169456051 | CEMENTSYS KPT1502-CDS OIS XPDR 15/3 |
Trademark Results [KyphoPak]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 KYPHOPAK 76220779 2540091 Live/Registered |
MEDTRONIC HOLDING COMPANY SARL 2001-03-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.