Identity
- Trade Name
- Apollo Anterior Cervical Plate System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Apollo Plate 2 Level 26mm FDA UDI
- Model / Reference
- 115-002-26 FDA UDI
- Description
- Apollo Plate 2 Level 26mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B521115002260 FDA UDI
- 510(k) Number
- K210325 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal 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
Category: Spinal fixation plate, non-bioabsorbable
Apollo Anterior Cervical Plate System by Aurora Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal fixation plate, non-bioabsorbable.
- Zavation — ZAVATION · Class II
- Cervalign — Xtant Medical Holdings, Inc. · Class II
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
- TSLP — Synthes · Class II
- AESCULAP — AESCULAP, INC. · Class II
- PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
- ACP — Nuvasive, Inc. · Class II
- uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Cleared under the same submission
K210325 also covers:
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, INC.
- Apollo Anterior Cervical Plate System — AURORA SPINE, 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
- Aurora Spine, Inc.
Sources (1)
- FDA UDI 3d867fea-94cb-47f3-8c98-c32b63ff58f4 35 fields · synced May 31, 2026