Identity
- Trade Name
- Phantom® Fibula Nail System FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- 6.8mm Distal Reamer, Cannulated, AO Quick Connect FDA UDI
- Model / Reference
- P36-920-6816 FDA UDI
- Description
- 6.8mm Distal Reamer, Cannulated, AO Quick Connect FDA UDI
Identifiers
- Catalog Number
- P36-920-6816 FDA UDI
- Primary DI / UDI-DI
- 00889795134660 FDA UDI
- 510(k) Number
- K234128 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone-resection orthopaedic reamer, single-use
Phantom® Fibula Nail System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-resection orthopaedic reamer, single-use.
- RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
- RAZOR Single-Use Acetabular Reamer — Razor Medical Instruments, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Disposable — Biomet Orthopedics, Inc. · Class I
- PANTA® — Newdeal Sas · Class I
- ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Tools - UFC — Trimed, INC. · Class I
Cleared under the same submission
K234128 also covers:
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
- Phantom® Fibula Nail System — Paragon 28
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
- Paragon 28
Sources (1)
- FDA UDI 454eea50-317a-4a0a-981f-ff87bab4db03 35 fields · synced Jun 1, 2026