Identity
- Trade Name
- Rhausler FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- MD DYNAMIC PLATE 63MM, 4LVL FDA UDI
- Model / Reference
- MD-C4463 FDA UDI
- Description
- MD DYNAMIC PLATE 63MM, 4LVL FDA UDI
Identifiers
- Catalog Number
- MD-C4463 FDA UDI
- Primary DI / UDI-DI
- 08500591420529 FDA UDI
- 510(k) Number
- K111272 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage 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
Yes
FDA UDI
Implantable
Yes
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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 63 Millimeter FDA UDI
Category: Metallic spinal interbody fusion cage
Rhausler by Rhausler, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic spinal interbody fusion cage.
- KODIAK CERVICAL IMPLANT, 14x16mm, 10mmx6° — MET 1 TECHNOLOGIES, LLC · Class II
- Peridot-PT Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
- CoRoent — Nuvasive, Inc. · Class II
- Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II
- MectaLIF 3D — Medacta International · Class II
- PILLAR TL — Orthofix US LLC · Class II
- Solar™ Interbody Fusion System — Degen Medical · Class II
- Peridot-TD Anterior Cervical Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
Cleared under the same submission
K111272 also covers:
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
- Rhausler — Rhausler, Inc.
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
- Rhausler, Inc.
Sources (1)
- FDA UDI b024e3d9-dfad-4e80-8a05-e5b6c8d86542 36 fields · synced Jun 6, 2026