Identity
- Trade Name
- PolyLock Midfoot FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- (not in use) FDA UDI
- Model / Reference
- TN-MF-7540 FDA UDI
- Description
- (not in use) FDA UDI
Identifiers
- Catalog Number
- TN-MF-7540 FDA UDI
- Primary DI / UDI-DI
- 00840124504721 FDA UDI
- 510(k) Number
- K202959 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, single-use
PolyLock Midfoot by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, single-use.
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Cleared under the same submission
K202959 also covers:
- LapiLock — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
- PolyLock Ankle Plates — FUSION ORTHOPEDICS, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI e1d41dc3-8c72-4820-b66d-370a28729185 35 fields · synced Jun 7, 2026