EpiFIX
GUDID B562PKEFC0416STUS0
Procedure Kit, Curved 4-Hole X 16mm EpiFIX Plate, Instruments and Solid Screws, Ti
WISHBONE MEDICAL, INC.
Growth-correction orthopaedic fixation plate kit| Primary Device ID | B562PKEFC0416STUS0 |
| NIH Device Record Key | d19870e8-e360-48b1-bded-63160bc3d21f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EpiFIX |
| Version Model Number | PK-EFC0416ST-US |
| Company DUNS | 062355158 |
| Company Name | WISHBONE MEDICAL, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B562PKEFC0416STUS0 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K182704
FDA Product Code
| OBT | Plate, Bone, Growth Control, Pediatric, Epiphysiodesis |
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 | 2021-03-23 |
| Device Publish Date | 2021-03-15 |
On-Brand Devices [EpiFIX]
| B562EFTEMPSNSUS0 | EPIFIX TEMPLATES, NON-STERILE US |
| B562EFTEMPSNS0 | EPIFIX TEMPLATES, NON-STERILE |
| B562PKEFC0432TUS0 | Procedure Kit, Curved 4 hole x 32mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0432T0 | Procedure Kit, Curved 4 hole x 32mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0432SUS0 | Procedure Kit, Curved 4 hole x 32mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0432S0 | Procedure Kit, Curved 4 hole x 32mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0426SUS0 | Procedure Kit, Curved 4 hole x 26mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0426S0 | Procedure Kit, Curved 4 hole x 26mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0422SUS0 | Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0422S0 | Procedure Kit, Curved 4 hole x 22mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0416TUS0 | Procedure Kit, Curved 4 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0416T0 | Procedure Kit, Curved 4 hole x 16mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0416SUS0 | Procedure Kit, Curved 4 hole x 16mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0416S0 | Procedure Kit, Curved 4 hole x 16mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0414TUS0 | Procedure Kit, Curved 4 hole x 14mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0414T0 | Procedure Kit, Curved 4 hole x 14mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0414SUS0 | Procedure Kit, Curved 4 hole x 14mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0414S0 | Procedure Kit, Curved 4 hole x 14mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0224TUS0 | Procedure Kit, Curved 2 hole x 24mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0224T0 | Procedure Kit, Curved 2 hole x 24mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0224SUS0 | Procedure Kit, Curved 2 hole x 24mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0224S0 | Procedure Kit, Curved 2 hole x 24mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0222TUS0 | Procedure Kit, Curved 2 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0222T0 | Procedure Kit, Curved 2 hole x 22mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0222SUS0 | Procedure Kit, Curved 2 hole x 22mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0222S0 | Procedure Kit, Curved 2 hole x 22mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0220TUS0 | Procedure Kit, Curved 2 hole x 20mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0220T0 | Procedure Kit, Curved 2 hole x 20mm EpiFIX Plate, Instruments and Screws, Ti |
| B562PKEFC0220SUS0 | Procedure Kit, Curved 2 hole x 20mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0220S0 | Procedure Kit, Curved 2 hole x 20mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0216SUS0 | Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0216S0 | Procedure Kit, Curved 2 hole x 16mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0212SUS0 | Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0212S0 | Procedure Kit, Curved 2 hole x 12mm EpiFIX Plate, Instruments and Screws, SS |
| B562PKEFC0432STUS0 | Procedure Kit, Curved 4-Hole X 32mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0432ST0 | Procedure Kit, Curved 4-Hole X 32mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0432SSUS0 | Procedure Kit, Curved 4-Hole X 32mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0432SS0 | Procedure Kit, Curved 4-Hole X 32mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0426STUS0 | Procedure Kit, Curved 4-Hole X 26mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0426ST0 | Procedure Kit, Curved 4-Hole X 26mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0426SSUS0 | Procedure Kit, Curved 4-Hole X 26mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0426SS0 | Procedure Kit, Curved 4-Hole X 26mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0422STUS0 | Procedure Kit, Curved 4-Hole X 22mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0422ST0 | Procedure Kit, Curved 4-Hole X 22mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0422SSUS0 | Procedure Kit, Curved 4-Hole X 22mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0422SS0 | Procedure Kit, Curved 4-Hole X 22mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0416STUS0 | Procedure Kit, Curved 4-Hole X 16mm EpiFIX Plate, Instruments and Solid Screws, Ti |
| B562PKEFC0416ST0 | PK-EFC0416ST |
| B562PKEFC0416SSUS0 | Procedure Kit, Curved 4-Hole X 16mm EpiFIX Plate, Instruments and Solid Screws, SS |
| B562PKEFC0416SS0 | Procedure Kit, Curved 4-Hole X 16mm EpiFIX Plate, Instruments and Solid Screws, SS |
Trademark Results [EpiFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EPIFIX 98264729 not registered Live/Pending |
Insigna, Inc. 2023-11-10 |
 EPIFIX 85783893 4457711 Live/Registered |
MIMEDX GROUP, INC. 2012-11-20 |
 EPIFIX 77139171 3558220 Live/Registered |
MIMEDX GROUP, INC. 2007-03-23 |
 EPIFIX 73767700 1557813 Dead/Cancelled |
BAUERFEIND GMBH & CO. 1988-12-02 |
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