Identity
- Trade Name
- Healix FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Cann. Headed Screw 3.0mmD, 10mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine. FDA UDI
- Model / Reference
- CH-30-10 FDA UDI
- Description
- Cann. Headed Screw 3.0mmD, 10mmL The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810005660211 FDA UDI
- 510(k) Number
- K182949 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.0 Millimeter FDA UDILength — 10 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Healix by Nvision Biomedical Technologies, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K182949 also covers:
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Healix — NVISION BIOMEDICAL TECHNOLOGIES, 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
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI 8a558862-a7ac-4520-8131-be8c7d606313 36 fields · synced May 30, 2026