Identity
- Trade Name
- PANTA XL FDA UDI
- Generic Name
- Bone nail end-cap FDA UDI
- Device Name
- The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to prevent tissue ingrowth and facilitate future nail removal. FDA UDI
- Model / Reference
- 510004ND FDA UDI
- Description
- The long end cap is made from Titanium alloy and may be inserted into the distal nail threads to prevent tissue ingrowth and facilitate future nail removal. FDA UDI
Identifiers
- Catalog Number
- 510004ND FDA UDI
- Primary DI / UDI-DI
- 10381780044574 FDA UDI
- 510(k) Number
- K091788 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone nail end-cap 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
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
Category: Bone nail end-cap
Panta Xl by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone nail end-cap.
- Phantom® Fibula Nail System — Paragon 28 · Class II
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- PEDIATRIC LOCKING NAIL SYSTEM — Biomet Orthopedics, Inc. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- PNP Femur — ORTHOPEDIATRICS CORP. · Class II
- EXPert Nail — Synthes · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Newdeal Sas
Sources (1)
- FDA UDI a48bd13a-953b-4b93-8fba-46c49e577760 39 fields · synced May 29, 2026