Identity
- Trade Name
- DualX Fixed Drawbar T/PLIF FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- DualX Fixed Drawbar T/PLIF FDA UDI
- Model / Reference
- 12825004 FDA UDI
- Description
- DualX Fixed Drawbar T/PLIF FDA UDI
Identifiers
- Primary DI / UDI-DI
- B707128250040 FDA UDI
- 510(k) Number
- K181397 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
DualX Fixed Drawbar T/PLIF by Amplify Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
Cleared under the same submission
K181397 also covers:
- DUALX DUAL PORT CANNULA 30MM — AMPLIFY SURGICAL
- DUALX DUAL PORT CANNULA 50MM — AMPLIFY SURGICAL
- DUALX DUAL PORT CANNULA 70MM — AMPLIFY SURGICAL
- DUALX DUAL PORT CANNULA 70MM (USA) — AMPLIFY SURGICAL
- DUALX DUAL PORTAL CANNULA 100MM (USA) — AMPLIFY SURGICAL
- DUALX DUAL PORTAL FUSION GUIDE RIGHT — AMPLIFY SURGICAL
- DUALX DUAL PORTAL ROOT RETRACTOR — AMPLIFY SURGICAL
- DUALX DUAL PORTAL ROOT RETRACTOR BAYONET — AMPLIFY SURGICAL
- DUALX DUAL PORTAL ROTATORY HANDLE — AMPLIFY SURGICAL
- DUALX DUAL PORTAL SERIAL DILATOR #5 — AMPLIFY SURGICAL
- DUALX DUAL PORTAL SERIAL DILATOR #9 — AMPLIFY SURGICAL
- DUALX DUAL PORTAL SQUIRE CURETTE UP — AMPLIFY SURGICAL
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
- Amplify Surgical
Sources (1)
- FDA UDI c66e8b49-d0ae-430c-8d83-3a56acb7987f 35 fields · synced Jun 7, 2026