Identity
- Trade Name
- Monster Screw System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- Counter Lever/Holder, MONSTER BITE FDA UDI
- Model / Reference
- P24-905-0002 FDA UDI
- Description
- Counter Lever/Holder, MONSTER BITE FDA UDI
Identifiers
- Catalog Number
- P24-905-0002 FDA UDI
- Primary DI / UDI-DI
- 00889795036308 FDA UDI
- 510(k) Number
- K190586 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Monster Screw System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- ARx — Life Spine, Inc. · Class II
- JULIET INSTRUMENTATION — Spineart · Class II
- JOURNEY II XR — Smith & Nephew, Inc. · Class II
- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
- DISTAL TIBIAL PLATE HANDLE, RIGHT — Biomet Orthopedics, Inc. · Class I
Cleared under the same submission
K190586 also covers:
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw System — Paragon 28
- Monster Screw 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 602141fe-3e2b-4682-8b85-4994b85e34c3 35 fields · synced Jun 8, 2026