3.5mm x 10mm Ti Locking Screw
- Primary DI
- B562TLK35010US0
- Brand
- 3.5mm x 10mm Ti Locking Screw
- Company
- Wishbone Medical, Inc.
- Model
- TLK35010-US
- Catalog number
- TLK35010
- Published
- 2019-11-25
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| HWC | Screw, Fixation, Bone |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K180736 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| B562TLK35010US0 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthopaedic bone screw (non-sliding) | A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver. |
Regulatory Flags#
- DUNS number
- 062355158
- 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
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| B56251300MDG000G10 | WishBone Plate & Screw System | 51-300-MDG000G-1 | 51-300-MDG000G-1 | 2024-01-01 |
| B562TCX27008US0 | 2.7mm x 8mm Ti Cortical Screw | TCX27008-US | TCX27008 | 2019-11-25 |
| B562TCX27010US0 | 2.7mm x 10mm Ti Cortical Screw | TCX27010-US | TCX27010 | 2019-11-25 |
| B562TCX27012US0 | 2.7mm x 12mm Ti Cortical Screw | TCX27012-US | TCX27012 | 2019-11-25 |
| B562TCX27014US0 | 2.7mm x 14mm Ti Cortical Screw | TCX27014-US | TCX27014 | 2019-11-25 |
| B562TCX27016US0 | 2.7mm x 16mm Ti Cortical Screw | TCX27016-US | TCX27016 | 2019-11-25 |
| B562TCX27018US0 | 2.7mm x 18mm Ti Cortical Screw | TCX27018-US | TCX27018 | 2019-11-25 |
| B562TCX27020US0 | 2.7mm x 20mm Ti Cortical Screw | TCX27020-US | TCX27020 | 2019-11-25 |
| B562TCX27022US0 | 2.7mm x 22mm Ti Cortical Screw | TCX27022-US | TCX27022 | 2019-11-25 |
| B562TCX27024US0 | 2.7mm x 24mm Ti Cortical Screw | TCX27024-US | TCX27024 | 2019-11-25 |
| B562TCX27026US0 | 2.7mm x 26mm Ti Cortical Screw | TCX27026-US | TCX27026 | 2019-11-25 |
| B562TCX27028US0 | 2.7mm x 28mm Ti Cortical Screw | TCX27028-US | TCX27028 | 2019-11-25 |
| B562TCX27030US0 | 2.7mm x 30mm Ti Cortical Screw | TCX27030-US | TCX27030 | 2019-11-25 |
| B562TCX27032US0 | 2.7mm x 32mm Ti Cortical Screw | TCX27032-US | TCX27032 | 2019-11-25 |
| B562TCX27034US0 | 2.7mm x 34mm Ti Cortical Screw | TCX27034-US | TCX27034 | 2019-11-25 |
| B562TCX27036US0 | 2.7mm x 36mm Ti Cortical Screw | TCX27036-US | TCX27036 | 2019-11-25 |
| B562TCX27038US0 | 2.7mm x 38mm Ti Cortical Screw | TCX27038-US | TCX27038 | 2019-11-25 |
| B562TCX27040US0 | 2.7mm x 40mm Ti Cortical Screw | TCX27040-US | TCX27040 | 2019-11-25 |
| B562TCX27045US0 | 2.7mm x 45mm Ti Cortical Screw | TCX27045-US | TCX27045 | 2019-11-25 |
| B562TCX27050US0 | 2.7mm x 50mm Ti Cortical Screw | TCX27050-US | TCX27050 | 2019-11-25 |
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