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-7935 FDA UDI
- Description
- (not in use) FDA UDI
Identifiers
- Catalog Number
- TN-MF-7935 FDA UDI
- Primary DI / UDI-DI
- 00840124505124 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
The PolyLock Midfoot surgical drill guide is a single-use, hand-held device designed to facilitate precise bone drilling in orthopedic procedures. With its sturdy metal construction and adjustable graduations, this device provides optimal control and accuracy for surgeons.
Similar devices
Also classified as Surgical drill guide, single-use.
- Nuvo — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
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- ALARA® 11 Gauge Access Needle with Sheath - Diamond Tip — SURGENTEC LLC · Class I
- MEDENTiKA — Medentika GmbH · Class I
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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 94bf38cb-6e92-40ed-8a35-ebc36ffb2afa 35 fields · synced Aug 4, 2026