Identity
- Trade Name
- Additive Orthopaedics Locking Lattice System FDA UDI
- Generic Name
- Metallic osteotomy fusion cage, non-customized FDA UDI
- Device Name
- Additive Orthopaedics MPJ Plate Right FDA UDI
- Model / Reference
- AOLLPRMPJ-NL FDA UDI
- Description
- Additive Orthopaedics MPJ Plate Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850005508489 FDA UDI
- 510(k) Number
- K170214 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Metallic osteotomy fusion cage, non-customized FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Metallic osteotomy fusion cage, non-customized
Additive Orthopaedics Locking Lattice System by Additive Orthopaedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K170214 also covers:
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics Locking Lattice System — ADDITIVE ORTHOPAEDICS LLC
- Additive Orthopaedics MTP Revision Plate — ADDITIVE ORTHOPAEDICS 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
- Additive Orthopaedics Llc
Sources (1)
- FDA UDI be96bbed-8d07-42d3-b31b-d3dbe80b0541 35 fields · synced Jun 8, 2026