Identity
- Trade Name
- Jones Screw Instrument Kit for 5.5mm Screw FDA UDI
- Generic Name
- Surgical countersink, single-use FDA UDI
- Device Name
- surgical instrument or accessory for orthopedic bone fixation FDA UDI
- Model / Reference
- FJS 100 FDA UDI
- Description
- surgical instrument or accessory for orthopedic bone fixation FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840118114585 FDA UDI
- FDA Product Code
- HTY FDA UDI
- GMDN Term
- Surgical countersink, single-use 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
Yes
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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical countersink, single-use
Jones Screw Instrument Kit for 5.5mm Screw by Flower Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical countersink, single-use.
- Volition Plating System — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- GEO Bone Screw System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED · Class I
- CrossRoads Screw System — CROSSROADS EXTREMITY SYSTEMS LLC · Class I
- BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
- VIEW PLATING SYSTEM, REDUCE FRACTURE PLATING SYSTEM — Orthofix, Inc. · Class II
- FuzeFix Mini — FUSION ORTHOPEDICS, LLC · Class II
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
- Flower Orthopedics Corporation
Sources (1)
- FDA UDI 8d0a25ef-d399-4803-a37f-8d5bab2c9d76 33 fields · synced May 30, 2026