Identity
- Trade Name
- PANTA FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Device Name
- The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 10mm, 11mm, 12mm and 13mm, and lengths of 150mm, 180mm, 210mm and 240mm. Holes in the nail allow for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long. The nail is made from Titanium alloy. FDA UDI
- Model / Reference
- 500180ND FDA UDI
- Description
- The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 10mm, 11mm, 12mm and 13mm, and lengths of 150mm, 180mm, 210mm and 240mm. Holes in the nail allow for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long. The nail is made from Titanium alloy. FDA UDI
Identifiers
- Catalog Number
- 500180ND FDA UDI
- Primary DI / UDI-DI
- 10381780044529 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Arthrodesis intramedullary nail, non-distracting
Panta by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
Cleared under the same submission
K050882 also covers:
K091788 also covers:
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
- Newdeal Sas
Sources (1)
- FDA UDI abc921b6-329a-4a14-8a49-c3360c5eaa78 39 fields · synced May 29, 2026