Identity
- Trade Name
- Miltex® Padgett® FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Device Name
- Integra® Miltex® ERICH ARCH BAR MATERIAL 1 METER ROLL FDA UDI
- Model / Reference
- PM-670 FDA UDI
- Description
- Integra® Miltex® ERICH ARCH BAR MATERIAL 1 METER ROLL FDA UDI
Identifiers
- Catalog Number
- PM-670 FDA UDI
- Primary DI / UDI-DI
- 10381780038238 FDA UDI
- 510(k) Number
- K061271 FDA UDI
- FDA Product Code
- DYX FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic intraoperative positioning pin, single-use
The Miltex Padgett device is a nonimplantable, single-use orthopaedic intraoperative positioning pin designed to assist surgeons in positioning implants during orthopaedic procedures. By using the Miltex Padgett, healthcare professionals can ensure accurate and precise placement of implants, improving patient outcomes.
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Cleared under the same submission
K061271 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Integra LifeSciences Production Corporation
Sources (1)
- FDA UDI d320f1bf-4724-4083-b29d-e4fa84a170be 37 fields · synced Jul 21, 2026