Identity
- Trade Name
- PREMIER(TM) Anterior Cervical Plate System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 27.5MM MODIFIED PREMIER PLATE FDA UDI
- Model / Reference
- X1002127 FDA UDI
- Description
- 27.5MM MODIFIED PREMIER PLATE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00721902615726 FDA UDI
- 510(k) Number
- K992110 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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
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
Dimensions & Sizes
- Size
- Width — 27.5 Millimeter FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
PREMIER(TM) Anterior Cervical Plate System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — 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
- Xpert Wrist — NEWCLIP TECHNICS · 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
Cleared under the same submission
K992110 also covers:
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER(TM) Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER® Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER® Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER® Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER® Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, INC.
- PREMIER® Anterior Cervical Plate System — MEDTRONIC SOFAMOR DANEK, 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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 21d7c690-a09e-423d-83f5-cfb98e1e1ab4 36 fields · synced Jun 8, 2026