Identity
- Trade Name
- Mediant Anterior Cervical Plate FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- Mediant 4.5 x 18 mm Bone Screw FDA UDI
- Model / Reference
- 1214518 FDA UDI
- Description
- Mediant 4.5 x 18 mm Bone Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814033021259 FDA UDI
- 510(k) Number
- K173935 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone-screw internal spinal fixation system, sterile
Mediant Anterior Cervical Plate by Intelligent Implant Systems, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, sterile.
- Libra Pedicle Screw System — Spinal Balance, Inc. · Class II
- Easyspine — Ldr Spine USA · Class II
- SANTIS™ NON CANNULATED POLYAXIAL PEDICLE SCREW/ DIA.6.5mm/Length40mm -STERILE — Lanterna Medical Technologies · Class II
- Paeon Posterior Cervical Fixation System — Aegis Spine, Inc. · Class II
- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
- ROMEO Posterior Osteosynthesis system — Spineart · Class II
- VERTICALE — Silony Medical GmbH · Class II
- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
Cleared under the same submission
K173935 also covers:
- MEDIANT — INTELLIGENT IMPLANT SYSTEMS, LLC
- MEDIANT — INTELLIGENT IMPLANT SYSTEMS, LLC
- MEDIANT — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
- Mediant Anterior Cervical Plate — INTELLIGENT IMPLANT SYSTEMS, LLC
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
- Intelligent Implant Systems, Llc
Sources (1)
- FDA UDI b8c548b5-c4f1-4207-a141-0c7965a3ede7 35 fields · synced Jun 6, 2026