Futura™ CSI
GUDID 00846832006311
TORNIER, INC.
Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis| Primary Device ID | 00846832006311 |
| NIH Device Record Key | f94ef952-a461-4a27-a832-7f39518e0258 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Futura™ CSI |
| Version Model Number | CSI-10 |
| Company DUNS | 968990812 |
| Company Name | TORNIER, 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
| Outer Diameter | 10 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00846832006311 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032902
FDA Product Code
| HWC | Screw, Fixation, Bone |
| KYI | PROSTHESIS, WRIST, CARPAL TRAPEZIUM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [Futura™ CSI]
| 00846832006335 | CSI-12 |
| 00846832006328 | CSI-11 |
| 00846832006311 | CSI-10 |
| 00846832006304 | CSI-09 |
| 00846832006298 | CSI-08 |
| 00846832006281 | CSI-07 |
Trademark Results [Futura]
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