TC-100
- Primary DI
- 03596010178046
- Brand
- TC-100
- Company
- Smith & Nephew, Inc.
- Model
- 71143007
- Catalog number
- 71143007
- Device description
- WASHER 7.0MM OD
- Published
- 2015-08-29
- 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 |
|---|---|---|---|---|---|
| K210837 | 000 | Smith & Nephew Plates and Screws | Smith & Nephew, Inc. | 2021-06-29 | HRS |
| K213126 | 000 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws | Smith & Nephew, Inc. | 2022-09-29 | JDO |
| 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 |
|---|---|---|---|---|
| 23596010178040 | Package | GS1 | 6 | In Commercial Distribution |
| 03596010178046 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 23596010178040 | 23596010178040 | |
| 03596010178046 | 03596010178046 | 3596010178046 |
GMDN Terms#
| Term | Definition |
|---|---|
| Implantable bone washer | An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device. |
Contacts#
| Phone | |
|---|---|
| +1(800)238-7538 | GUDID@SMITH-NEPHEW.COM |
Regulatory Flags#
- DUNS number
- 045483575
- Device count
- 1
- DM exempt
- true
- Lot or batch
- true
- Expiration date on label
- true
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| 00885556833971 | Salto Talaris Total Ankle Prosthesis | MJV221T | MJV221T | 2022-12-22 |
| 00885556833988 | Salto Talaris Total Ankle Prosthesis | MJV229T | MJV229T | 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 |
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