Identity
- Trade Name
- Reform Ti Modular FDA UDI
- Generic Name
- Spinal bone screw head/rod adaptor FDA UDI
- Device Name
- Modular Offset Tulip Assembly, 29mm FDA UDI
- Model / Reference
- 39-WT-0429 FDA UDI
- Description
- Modular Offset Tulip Assembly, 29mm FDA UDI
Identifiers
- Catalog Number
- 39-WT-0429 FDA UDI
- Primary DI / UDI-DI
- 00840019938617 FDA UDI
- 510(k) Number
- K150856 FDA UDI
- FDA Product Code
- NKB FDA UDIOSH FDA UDIMNH FDA UDIMNI FDA UDIKWP FDA UDI
- GMDN Term
- Spinal bone screw head/rod adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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 bone screw head/rod adaptor
Reform Ti Modular by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Spinal bone screw head/rod adaptor.
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- VERTEFIX — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- TAURUS — CTL Medical Corporation · Class II
- Vertefix II — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
- DIPLOMAT — SIGNUS Medizintechnik GmbH · Class II
- Vertefix — ELITE SURGICAL SUPPLIES (PTY) LTD · Class II
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 cd62f885-3385-402d-8804-90340e169f9f 35 fields · synced Jun 6, 2026