Identity
- Trade Name
- Reform® POCT System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Add-on Implant with Lordotic Rod Kit FDA UDI
- Model / Reference
- 55-BK-0105 FDA UDI
- Description
- Add-on Implant with Lordotic Rod Kit FDA UDI
Identifiers
- Catalog Number
- 55-BK-0105 FDA UDI
- Primary DI / UDI-DI
- 00840019970532 FDA UDI
- 510(k) Number
- K162300 FDA UDI
- FDA Product Code
- NKG FDA UDIKWP FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3075 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbableBone-screw internal spinal fixation system rodSpinal fixation plate, non-bioabsorbableSpinal bone set screw
Reform® POCT System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone set screw.
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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.
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 158dcc56-4313-4b67-ae25-5dcb26d2cf7d 35 fields · synced May 30, 2026