Accord
- Primary DI
- 03596010500274
- Brand
- Accord
- Company
- Smith & Nephew, Inc.
- Model
- 71346150
- Catalog number
- 71346150
- Device description
- ACCORD 150MM TITANIUM PLATE
- Published
- 2015-08-30
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
smith-nephew.comProduct Codes#
| Code | Name |
|---|---|
| HRS | PLATE, FIXATION, BONE |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K223762 | 000 | Smith & Nephew ACCORD™ Cable System | Smith & Nephew | 2023-05-30 | HRS |
| K233949 | 000 | ACCORD Cable System | Smith & Nephew, Inc. | 2024-03-13 | JDQ |
| K993106 | 000 | SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) | Smith & Nephew, Inc. | 1999-12-09 | HRS |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 03596010500274 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 03596010500274 | 03596010500274 | 3596010500274 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic fixation plate, non-bioabsorbable, sterile | A sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)821-5700 | gudid@smith-nephew.com |
| +1(800)238-7538 | GUDID@SMITH-NEPHEW.COM |
Regulatory Flags#
- DUNS number
- 045483575
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
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|---|---|---|---|---|
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| 00885556833971 | Salto Talaris Total Ankle Prosthesis | MJV221T | MJV221T | 2022-12-22 |
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| 00885556834251 | Silicone Toe System | CGT-305T | CGT-305T | 2022-12-22 |
| 00885556834299 | Silicone Toe System | CGT-505T | CGT-505T | 2022-12-22 |
| 00885556835029 | Ti6 Internal Fixation System | DS1007 | DS1007 | 2022-12-22 |
| 00885556835203 | Surgical Instruments | FS-1006 | FS-1006 | 2022-12-22 |
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| 00885556837856 | Total Foot System 2 | 2204250 | 2204250 | 2022-12-22 |
| 00885556838785 | Total Foot System 2 | 2823027 | 2823027 | 2022-12-21 |
| 00885556841631 | XT Revision Ankle Replacement System | MJU984T | MJU984T | 2022-12-21 |
| 00885556841778 | XT Revision Ankle Replacement System | MJV222T | MJV222T | 2022-12-21 |
| 00885556841785 | XT Revision Ankle Replacement System | MJV223T | MJV223T | 2022-12-21 |
| 00885556854921 | Freedom Wrist Arthroplasty System | 348047 | 348047 | 2022-12-22 |
| 00885556856680 | Surgical Instruments | EXT-200-00 | EXT-200-00 | 2022-12-22 |
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