Identity
- Trade Name
- Reform Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw head/rod adaptor FDA UDI
- Device Name
- Modular Polyaxial Reduction Tulip Assembly FDA UDI
- Model / Reference
- 39-MT-0302 FDA UDI
- Description
- Modular Polyaxial Reduction Tulip Assembly FDA UDI
Identifiers
- Catalog Number
- 39-MT-0302 FDA UDI
- Primary DI / UDI-DI
- 00815362028698 FDA UDI
- 510(k) Number
- K150856 FDA UDI
- FDA Product Code
- KWP FDA UDIMNH FDA UDIMNI FDA UDIOSH FDA UDINKB FDA UDI
- GMDN Term
- Spinal bone screw head/rod adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 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 bone screw head/rod adaptor
Reform Pedicle Screw System by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal bone screw head/rod adaptor.
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Cleared under the same submission
K150856 also covers:
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw System — Precision Spine, Inc.
- Reform Pedicle Screw 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Precision Spine, Inc.
Sources (1)
- FDA UDI dcb9b069-5844-4fe1-b10d-de7a62cf755c 35 fields · synced May 30, 2026