Identity
- Trade Name
- Guide S-PI / W5.0 FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Drill Guide for SF Push-in Anchor Portfolio Integrated Wrench 5.0 FDA UDI
- Model / Reference
- Guide S-PI / W5.0 FDA UDI
- Description
- Drill Guide for SF Push-in Anchor Portfolio Integrated Wrench 5.0 FDA UDI
Identifiers
- Catalog Number
- G04-001 FDA UDI
- Primary DI / UDI-DI
- 07649990202297 FDA UDI
- 510(k) Number
- K240288 FDA UDI
- FDA Product Code
- GAT FDA UDIHTY FDA UDIHWC FDA UDIMAI FDA UDINKB FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 FDA UDI888.3040 FDA UDI888.3030 FDA UDI888.3070 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
Guide S-PI / W5.0 by Surgical Fusion Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical drill guide, reusable.
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- Truliant — Exactech, Inc. · Class II
- Vantage — Exactech, Inc. · Class II
- Legion — Smith & Nephew, Inc. · Class II
- Hintermann Series — Dt Medtech, LLC · Class I
Cleared under the same submission
K240288 also covers:
- Drill S-PI-A1.6 — Surgical Fusion Technologies GmbH
- Drill S-PI-A2.3 — Surgical Fusion Technologies GmbH
- Drill S-PI-A3.0 — Surgical Fusion Technologies GmbH
- Footswitch SupraFuser — Surgical Fusion Technologies GmbH
- Handpiece Front Cover — Surgical Fusion Technologies GmbH
- Handpiece SupraFuser — Surgical Fusion Technologies GmbH
- SF Push-in Anchor 1.6 — Surgical Fusion Technologies GmbH
- SF Push-in Anchor 2.3 — Surgical Fusion Technologies GmbH
- SF Push-in Anchor 3.0 — Surgical Fusion Technologies GmbH
- Sonotrode S-PI — Surgical Fusion Technologies GmbH
- Stopper S-PI-A1.6 — Surgical Fusion Technologies GmbH
- Stopper S-PI-A2.3 — Surgical Fusion Technologies GmbH
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
- Surgical Fusion Technologies GmbH
Sources (1)
- FDA UDI 4d86ee96-fbf3-40b5-b679-9f762fa8c233 36 fields · synced Jun 1, 2026