FDA UDI
In Commercial Distribution
🇺🇸 United States
PolyLock Ankle
DI: 00840124520318
·
Model: TN-AK-0004
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PolyLock Ankle
- Primary DI
- 00840124520318
- Version / Model
- TN-AK-0004
- Catalog Number
- TN-AK-0004
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-16
- Public Version
- 1
- Public Version Date
- 2025-05-26
- Public Version Status
- New
- Public Device Record Key
- a8128cd8-6a60-4127-9838-3ca7b2e286c0
Device Description
Plate Bending Pliers
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HTC | Pliers, Surgical | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47637 | Bone fixation plate pliers | A manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124520318 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211843 | 000 |