Identity
- Trade Name
- CODA™ Anterior Cervical Plate System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- 2 Level Plate FDA UDI
- Model / Reference
- 58-102202028 FDA UDI
- Description
- 2 Level Plate FDA UDI
Identifiers
- Catalog Number
- 1022-02-028 FDA UDI
- Primary DI / UDI-DI
- 00840298701117 FDA UDI
- 510(k) Number
- K222493 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 28 Millimeter FDA UDI
Category: Spinal fixation plate, non-bioabsorbable
CODA™ Anterior Cervical Plate System by Pioneer Surgical Technology, 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
- 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
- Rexious — Dio Medical Co., Ltd. · Class II
Cleared under the same submission
K222493 also covers:
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc.
- CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, 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
- Pioneer Surgical Technology, Inc.
Sources (1)
- FDA UDI 3a3e6a0f-c127-4e94-9819-64a59f3fdddf 37 fields · synced May 30, 2026