Identity
- Trade Name
- Panta® 2 FDA UDI
- Generic Name
- Bone nail driver FDA UDI
- Device Name
- Arthrodesis Nail System Compression Device FDA UDI
- Model / Reference
- PAN-1010-0231 FDA UDI
- Description
- Arthrodesis Nail System Compression Device FDA UDI
Identifiers
- Catalog Number
- PAN-1010-0231 FDA UDI
- Primary DI / UDI-DI
- 10381780505563 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone nail driver FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone nail driver
Panta® 2 by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone nail driver.
- MEDLINEUNITE — MEDLINE INDUSTRIES, INC. · Class I
- WIN NAIL PUSHER 0 CM OFFSET — Biomet Orthopedics, Inc. · Class I
- Phoenix — Zimmer, Inc. · Class I
- PENDING — MEDLINE INDUSTRIES, INC. · Class II
- RAVINE® Lateral Access System — K2M, INC. · Class I
- Panta 2 Arthrodesis Nail System — Smith & Nephew, Inc. · Class I
- Panta 2 Arthrodesis Nail System — Smith & Nephew, Inc. · Class I
- Panta 2 Arthrodesis Nail System — Smith & Nephew, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI 6ad066d7-29f3-46ab-8a70-002d0077da59 37 fields · synced May 30, 2026