CENTERPIECE™ Plate Fixation System
GUDID 00613994866103
SCREW X0810577 CEN TI DEEP DRIVE 2.6X9
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00613994866103 |
| NIH Device Record Key | 1b80025a-e7ef-4649-9e66-466158f755ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CENTERPIECE™ Plate Fixation System |
| Version Model Number | X0810577 |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 2.6 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
| Length | 9 Millimeter |
| Outer Diameter | 2.6 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994866103 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K050082
FDA Product Code
| NQW | ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam Sterilization
[00613994866103]
Moist Heat or Steam 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 | 2015-09-01 |
On-Brand Devices [CENTERPIECE™ Plate Fixation System]
| 00613994866158 | SCREW X0810582 CEN TI DEEP DRIVE 3.0X11 |
| 00613994866141 | SCREW X0810581 CEN TI DEEP DRIVE 3.0X9 |
| 00613994866134 | SCREW X0810580 CEN TI DEEP DRIVE 3.0X7 |
| 00613994866127 | SCREW X0810579 CEN TI DEEP DRIVE 3.0X5 |
| 00613994866110 | SCREW X0810578 CEN TI DEEP DRIVE 2.6X11 |
| 00613994866103 | SCREW X0810577 CEN TI DEEP DRIVE 2.6X9 |
| 00613994866097 | SCREW X0810576 CEN TI DEEP DRIVE 2.6X7 |
| 00613994866080 | SCREW X0810575 CEN TI DEEP DRIVE 2.6X5 |
| 00613994270825 | Screw X1006038 3.0 x 4mm |
| 00613994270818 | Screw X1006037 2.6 x 4mm |
| 00721902799105 | CASE 176-859R LP SCREW CADDY |
| 00721902742835 | BONE SCREW 853-511 3.0 X 11MM |
| 00721902742828 | BONE SCREW 853-509 3.0 X 9MM |
| 00721902742811 | BONE SCREW 853-507 3.0 X 7MM |
| 00721902742804 | BONE SCREW 853-505 3.0 X 5MM |
| 00721902742781 | BONE SCREW 853-471 2.6 X 11MM |
| 00721902742774 | BONE SCREW 853-469 2.6 X 9MM |
| 00721902742750 | BONE SCREW 853-467 2.6 X 7MM |
| 00721902742743 | BONE SCREW 853-465 2.6 X 5MM |
| 00721902569227 | PLATE 853-410 10MM GRFT PLT |
| 00721902569203 | TRAUMA 853-010 10MM OD PLATE |
| 00721902427381 | 18MM GRAFT PLATE |
| 00721902427374 | PLATE 853-416 16MM GRFT PLT |
| 00721902427367 | PLATE 853-414 14MM GRFT PLT |
| 00721902427350 | PLATE 853-412 12MM GRFT PLT |
| 00721902427312 | PLATE 853-018 18MM OD |
| 00721902427305 | TRAUMA 853-016 16MM OD PLATE |
| 00721902427299 | TRAUMA 853-014 14MM OD PLATE |
| 00721902427282 | TRAUMA 853-012 12MM OD PLATE |
| 00885074527765 | 8MM GRAFT PLATE |
| 00885074527758 | OD LAT WIDE MOUTH PLATE 18MM |
| 00885074527741 | OD LAT WIDE MOUTH PLATE 16MM |
| 00885074527734 | PLATE 853014LW OD LAT WIDE MOUTH 14MM |
| 00885074527727 | PLATE 853012LW OD LAT WIDE MOUTH 12MM |
| 00885074527710 | PLATE 853010LW OD LAT WIDE MOUTH 10MM |
| 00885074527703 | OD LAT WIDE MOUTH PLATE 8MM |
| 00885074527598 | 8MM OD PLATE |
| 00885074527543 | PLATE 8530000 TROUGH PLATE |
| 00885074317632 | GP LATERAL HOLE PLATE 16MM |
| 00885074317625 | PLATE 853414LH GP LATERAL HOLE 14MM |
| 00885074317601 | PLATE 853412LH GP LATERAL 12MM |
| 00885074317595 | PLATE 853410LH GP LATERAL HOLE 10MM |
| 00885074317571 | GP LATERAL HOLE PLATE 8MM |
| 00885074317564 | OD WIDE MOUTH PLATE 18MM |
| 00885074317540 | OD LATERAL HOLE PLATE 18MM |
| 00885074317533 | OD WIDE MOUTH PLATE 16MM |
| 00885074317519 | OD LATERAL HOLE PLATE 16MM |
| 00885074317502 | PLATE 853014WM OD WIDE MOUTH 14MM |
| 00885074317489 | PLATE 853014LH OD LATERAL HOLE 14MM |
| 00885074317472 | PLATE 853012WM OD WIDE MOUTH 12MM |
Trademark Results [CENTERPIECE]
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