Identity
- Trade Name
- CAPTURE™ High Torque Screw System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 7.0mm screws. Instruments are provided to assist with the implants. FDA UDI
- Model / Reference
- HITORQ7IMP FDA UDI
- Description
- The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 7.0mm screws. Instruments are provided to assist with the implants. FDA UDI
Identifiers
- Catalog Number
- HITORQ7IMP FDA UDI
- Primary DI / UDI-DI
- 10381780064558 FDA UDI
- 510(k) Number
- K092440 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
- Not 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CAPTURE™ High Torque Screw System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092440 also covers:
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, Inc.
- CAPTURE™ High Torque Screw System — Ascension Orthopedics, 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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI e6562818-d168-459f-9aed-46e5d99f1f83 37 fields · synced Jun 1, 2026