CD Horizon™ Astute™ Spinal System
GUDID 00763000312916
PEEK ROD 1608451025 6.0 X 6.9MM STR 25MM
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, sterile| Primary Device ID | 00763000312916 |
| NIH Device Record Key | 12283ee0-2ab4-4f87-8af3-324d0c1851b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CD Horizon™ Astute™ Spinal System |
| Version Model Number | 1608451025 |
| 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 | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
| Outer Diameter | 25 Millimeter |
| Length | 6 Millimeter |
| Width | 6.9 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000312916 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K191066
FDA Product Code
| NKB | Thoracolumbosacral pedicle screw system |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-17 |
| Device Publish Date | 2020-08-09 |
On-Brand Devices [CD Horizon™ Astute™ Spinal System]
| 00763000313029 | PEEK ROD 1608451080 6.0 X 6.9MM STR 80MM |
| 00763000312954 | PEEK ROD 1608451045 6.0 X 6.9MM STR 45MM |
| 00763000312947 | PEEK ROD 1608451040 6.0 X 6.9MM STR 40MM |
| 00763000312930 | PEEK ROD 1608451035 6.0 X 6.9MM STR 35MM |
| 00763000312923 | PEEK ROD 1608451030 6.0 X 6.9MM STR 30MM |
| 00763000312916 | PEEK ROD 1608451025 6.0 X 6.9MM STR 25MM |
| 00763000313128 | PEEK ROD 1608451130 6.0X6.9MM STR 130MM |
| 00763000313111 | PEEK ROD 1608451125 6.0X6.9MM STR 125MM |
| 00763000313104 | PEEK ROD 1608451120 6.0X6.9MM STR 120MM |
| 00763000313098 | PEEK ROD 1608451115 6.0X6.9MM STR 115MM |
| 00763000313081 | PEEK ROD 1608451110 6.0X6.9MM STR 110MM |
| 00763000313074 | PEEK ROD 1608451105 6.0X6.9MM STR 105MM |
| 00763000313067 | PEEK ROD 1608451100 6.0X6.9MM STR 100MM |
| 00763000313050 | PEEK ROD 1608451095 6.0 X 6.9MM STR 95MM |
| 00763000313043 | PEEK ROD 1608451090 6.0 X 6.9MM STR 90MM |
| 00763000313036 | PEEK ROD 1608451085 6.0 X 6.9MM STR 85MM |
| 00763000313012 | PEEK ROD 1608451075 6.0 X 6.9MM STR 75MM |
| 00763000313005 | PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM |
| 00763000312992 | PEEK ROD 1608451065 6.0 X 6.9MM STR 65MM |
| 00763000312985 | PEEK ROD 1608451060 6.0 X 6.9MM STR 60MM |
| 00763000312978 | PEEK ROD 1608451055 6.0 X 6.9MM STR 55MM |
| 00763000312961 | PEEK ROD 1608451050 6.0 X 6.9MM STR 50MM |
| 00613994667434 | SET SCREW 5630724 BRKOFF 6.0PEEK STERBX4 |
| 00763000313333 | SET SCREW 5530620 BREAKOFF 6.0 PEEK STER |
Trademark Results [CD Horizon]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CD HORIZON 75079759 2108361 Live/Registered |
WARSAW ORTHOPEDIC, INC. 1996-03-28 |
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