Identity
- Trade Name
- Paradigm Navigated Drill Guide FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Navigated Drill Guide FDA UDI
- Model / Reference
- 1200024 FDA UDI
- Description
- Navigated Drill Guide FDA UDI
Identifiers
- Catalog Number
- 1200024 FDA UDI
- Primary DI / UDI-DI
- 00850042604274 FDA UDI
- 510(k) Number
- K250879 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical drill guide, reusable
Paradigm Navigated Drill Guide by Proprio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical drill guide, reusable.
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Cleared under the same submission
K250879 also covers:
- Paradigm Depth Cannula, 2mm — Proprio
- Paradigm Depth Cannula, 5mm — Proprio
- Paradigm Drill Bit, 2.1 mm — Proprio
- Paradigm Drill Bit, 3.0 mm — Proprio
- Paradigm Drill Guide Trocar — Proprio
- Paradigm Navigated Drill Guide Case Assembly — Proprio
- Paradigm Navigated Drill Guide Case Lid — Proprio
- Paradigm Navigated Drill Guide Case Tray — Proprio
- Paradigm Navigated Drill Guide Set — Proprio
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
- Proprio
Sources (1)
- FDA UDI 99a954df-1985-49ec-90b5-7e19702097c6 36 fields · synced May 30, 2026