Identity
- Trade Name
- REFORM FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system hook FDA UDI
- Device Name
- Reform Hook Angled Hook, MD, Right (QTY 16) FDA UDI
- Model / Reference
- 0233RM FDA UDI
- Description
- Reform Hook Angled Hook, MD, Right (QTY 16) FDA UDI
Identifiers
- Catalog Number
- 39-TH-0401 FDA UDI
- Primary DI / UDI-DI
- 00815362029695 FDA UDI
- 510(k) Number
- K130279 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWP FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system hook 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system hook
Reform by Precision Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system hook.
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- PASS LP PASS TL — Medicrea International SA · Class II
- DENALI® Spinal System — K2M, INC. · Class II
- MESA® Small Stature Spinal System — K2M, INC. · Class II
- TSRH® Spinal System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- ReLine — Nuvasive, Inc. · Class II
Cleared under the same submission
K130279 also covers:
- REFORM — 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 |
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Manufacturer
- Manufacturer
- Precision Spine, Inc.
Sources (1)
- FDA UDI 5bcfeda4-c43e-4748-bc1c-1581859921dd 35 fields · synced May 30, 2026