Identity
- Trade Name
- Alians Elbow FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Plates Alians Elbow, Plates Alians Elbow S EUDAMED
- Model / Reference
- NTGQ1D-ST EUDAMEDFDA UDI
Identifiers
- Catalog Number
- NTGQ1D-ST FDA UDI
- Primary DI / UDI-DI
- 03700569659653 EUDAMEDFDA UDI
- Basic UDI-DI
- 3700569600028L EUDAMED
- 510(k) Number
- K152289 FDA UDI
- FDA Product Code
- HRS FDA UDI
- EMDN Code
- P09120599 BONE FIXATION PLATES - OTHER EUDAMED
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic fixation plate, non-bioabsorbable
Alians Elbow by Newclip Technics — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II
Cleared under the same submission
K152289 also covers:
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
- Alians Elbow — NEWCLIP TECHNICS
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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
- Newclip Technics
Sources (2)
- FDA UDI 3f48735a-8d3e-4858-9f85-8cfcb984df8f 34 fields · synced Aug 1, 2026
- EUDAMED a7cc5519-c72b-44cb-b4bd-907075983275 61 fields · synced Aug 1, 2026