Identity
- Trade Name
- Paradigm Drill Guide Trocar FDA UDI
- Generic Name
- Surgical optical-tracking spatial marker connector FDA UDI
- Device Name
- Drill Guide Trocar FDA UDI
- Model / Reference
- 1200028 FDA UDI
- Description
- Drill Guide Trocar FDA UDI
Identifiers
- Catalog Number
- 1200028 FDA UDI
- Primary DI / UDI-DI
- 00850042604311 FDA UDI
- 510(k) Number
- K250879 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Surgical optical-tracking spatial marker connector 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 optical-tracking spatial marker connector
Paradigm Drill Guide Trocar by Proprio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical optical-tracking spatial marker connector.
- 7D Surgical Biopsy Arm — 7D Surgical ULC · Class II
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- 7D Surgical Universal Array Angled Adaptor — 7D Surgical ULC · Class II
- 7D Surgical Universal Clamp Large — 7D Surgical ULC · Class II
- 11-0052 7D Flex Rod Connector - ø5.5mm - 150mm — 7D Surgical ULC · Class II
- 7D Surgical Flex Array — 7D Surgical ULC · Class II
- ENVISION 3D: PEDICLE PROBE — 7D Surgical ULC · Class II
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 Navigated Drill Guide — 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 |
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Manufacturer
- Manufacturer
- Proprio
Sources (1)
- FDA UDI 3348e25d-c923-4b81-8bf7-e108254ba9c0 36 fields · synced Jun 6, 2026