Flow-Nail™
- Primary DI
- B267101LS1085R0
- Brand
- Flow-Nail™
- Company
- Flow-FX
- Model
- 101LS-1085R
- Catalog number
- 101LS-1085R
- Device description
- FN 85mm Lag Screw
- Published
- 2022-02-08
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K140601 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B267101LS1085R0 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw, non-bioabsorbable, non-sterile | A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 079293587
- Device count
- 1
- Lot or batch
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B2672CAN3500 | 2-CAN™ | 2CAN350 | 2CAN350 | 2025-07-11 |
| B267101120 | Flow-Screw™ | 101-12 | 101-12 | 2020-12-18 |
| B267101270 | Flow-Nail™ | 101-27 | 101-27 | 2020-12-18 |
| B267101410 | Flow-Nail™ | 101-41 | 101-41 | 2020-12-18 |
| B267101540 | Flow-Nail™ | 101-54 | 101-54 | 2020-12-18 |
| B26710218000 | Flow-Screw™ | 102-18-00 | 102-18-00 | 2020-12-18 |
| B26710218010 | Flow-Screw™ | 102-18-01 | 102-18-01 | 2020-12-18 |
| B26710218100 | Flow-Screw™ | 102-18-10 | 102-18-10 | 2020-12-18 |
| B26710218110 | Flow-Screw™ | 102-18-11 | 102-18-11 | 2020-12-18 |
| B26710218200 | Flow-Screw™ | 102-18-20 | 102-18-20 | 2020-12-18 |
| B26710218210 | Flow-Screw™ | 102-18-21 | 102-18-21 | 2020-12-18 |
| B2675510700 | Flow-Screw™ | 55-1070 | 55-1070 | 2024-07-22 |
| B2675520750 | Flow-Screw™ | 55-2075 | 55-2075 | 2024-07-22 |
| B2675510600 | Flow-Screw™ | 55-1060 | 55-1060 | 2018-06-22 |
| B2675510650 | Flow-Screw™ | 55-1065 | 55-1065 | 2018-06-22 |
| B2675520650 | Flow-Screw™ | 55-2065 | 55-2065 | 2018-06-22 |
| B267A600 | Flow-Nail™ | A60 | A60 | 2018-06-21 |
| B267C400 | Flow-Nail™ | C40 | C40 | 2018-06-22 |
| B267101290 | Flow-Nail™ | 101-29 | 101-29 | 2022-02-08 |
| B26710230050 | Flow-Screw™ | 102-30-05 | 102-30-05 | 2024-08-29 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07898624869669 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-21 |
| 07898624869140 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869157 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869164 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869171 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869188 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869195 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869201 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869218 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869225 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869232 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869249 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869256 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869263 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869270 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869287 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869294 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869300 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869317 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
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| 07898624869348 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869355 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869362 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869379 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869386 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869393 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869409 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869416 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869423 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |
| 07898624869430 | NEONAIL | Neoortho Produtos Ortopédicos S/A. | HSB | 2015-10-06 |