Identity
- Trade Name
- Tray SF Push-in Anchor Portfolio FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- Tray SF Push-in Anchor Portfolio FDA UDI
- Model / Reference
- Tray SF Push-in Anchor Portfolio FDA UDI
- Description
- Tray SF Push-in Anchor Portfolio FDA UDI
Identifiers
- Catalog Number
- T04-003 FDA UDI
- Primary DI / UDI-DI
- 07649990202365 FDA UDI
- 510(k) Number
- K240288 FDA UDI
- FDA Product Code
- GAT FDA UDIHTY FDA UDIHWC FDA UDIMAI FDA UDINKB FDA UDI
- GMDN Term
- Instrument tray, 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: Instrument tray, reusable
Tray SF Push-in Anchor Portfolio by Surgical Fusion Technologies GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument tray, reusable.
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- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- Instrument Case — Katena Products, Inc. · Class I
- Hu-Friedy — Hu-Friedy Manufacturing Co., LLC · Class I
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
- SHEFFIELD RING FIXATOR — Orthofix, Inc. · Class II
- MİKRO — SAMSUN MİKRO CERRAHİ ALETLER İMALAT SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
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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
- Guide S-PI / W5.0 — 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
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 29451b53-b06c-4fe0-b0c9-a0733045e1c2 36 fields · synced Jun 1, 2026