FDA UDI
In Commercial Distribution
🇺🇸 United States
PolyLock Ankle
DI: 00840124520981
·
Model: TN-AK-0006
·
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
- 00840124520981
- Version / Model
- TN-AK-0006
- Catalog Number
- TN-AK-0006
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-27
- Public Version
- 2
- Public Version Date
- 2025-06-11
- Public Version Status
- Update
- Public Device Record Key
- 40b8a498-d58e-4602-9a27-d79cf601d30f
Device Description
Hintermann Distractor 15cm
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| PLF | Bone Wedge | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63917 | Orthopaedic bone fixation plate spacer | A small, non-sterile, threaded implantable device intended to be used to maintain a space between an orthopaedic bone fixation plate and the bone to which the plate is fixed, to reduce complications of impaired blood flow in the periosteum. It is made of metal and is screwed into an empty screw hole, producing a short projection on the inside of the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840124520981 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211843 | 000 |