10mm Evans Plate
- Primary DI
- 00812926027203
- Brand
- 10mm Evans Plate
- Company
- Trilliant Surgical, LLC
- Model
- 300-54-210
- Published
- 2017-03-15
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HRS | Plate, Fixation, Bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K130964 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00812926027203 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00812926027203 | 00812926027203 | 812926027203 | 0812926027203 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 828829072
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00810028393431 | STAR PSI Tibia Cut Guide | 601-01-000 | 2022-11-30 | |
| 00810028393448 | STAR PSI Tibia Anatomical Model | 601-01-001 | 2022-11-30 | |
| 00810028393455 | STAR PSI Talus Cut Guide | 601-02-000 | 2022-11-30 | |
| 00810028393462 | STAR PSI Talus Anatomical Model | 601-02-001 | 2022-11-30 | |
| 00810028394971 | STAR PSI Standard Bundle with Anatomical Models | 601-00-001 | 2022-11-30 | |
| 00812926027210 | 12mm Evans Plate | 300-54-212 | 2017-03-15 | |
| 00812926027791 | Tissue Retractor | 317-00-007 | 2018-09-23 | |
| 00812926027869 | Subtalar Implant System Sterilization Tray Lid | 112-99-011 | 2018-09-23 | |
| 00812926028514 | 10 Hole Gridlock Helical Plate, Right | 300-65-004 | 2018-10-15 | |
| 00812926027036 | Tiger | 210-00-102 | 2018-09-23 | |
| 00812926027890 | Tiger | 210-99-112 | 2018-09-23 | |
| 00812926028002 | Gridlock | 320-99-113 | 2018-09-23 | |
| 00812926028026 | Gridlock | 310-00-021 | 2018-09-23 | |
| 00190446972020 | Generic Instrument | 215-00-007 | 2026-07-16 | |
| 00190446972037 | Generic Instrument | 215-00-008 | 2026-07-16 | |
| 00190446900498 | Arsenal Foot | 330-60-007 | 2026-06-25 | |
| 00190446900504 | Arsenal Foot | 330-60-008 | 2026-06-25 | |
| 00190446917861 | Arsenal Foot | 330-01-215 | 2026-06-25 | |
| 00190446917878 | Arsenal Foot | 330-01-216 | 2026-06-25 | |
| 00190446932406 | Arsenal Foot | 330-22-013 | 2026-06-25 |
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