Identity
- Trade Name
- Reform POCT System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- A-Shape, Occipital Plate, 25-35mm FDA UDI
- Model / Reference
- 55-OA-0201 FDA UDI
- Description
- A-Shape, Occipital Plate, 25-35mm FDA UDI
Identifiers
- Catalog Number
- 55-OA-0201 FDA UDI
- Primary DI / UDI-DI
- 00815362024867 FDA UDI
- FDA Product Code
- NKG FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 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
No
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
Reform POCT System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162300 also covers:
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
K172495 also covers:
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision Spine, Inc.
- Reform POCT System — Precision 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
- Precision Spine, Inc.
Sources (1)
- FDA UDI f0d8c414-6d07-4355-afcf-4e29e7f93416 35 fields · synced Jun 8, 2026