Identity
- Trade Name
- CAPTURE™ Screw System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- The Capture Screw System is comprised of Low Profile screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The low profile, cannulated screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0, and 4.0mm diameters with lengths of 6 – 50mm. The system includes instruments to facilitate the placement of the screws. FDA UDI
- Model / Reference
- CAPLOPROIMP FDA UDI
- Description
- The Capture Screw System is comprised of Low Profile screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The low profile, cannulated screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0, and 4.0mm diameters with lengths of 6 – 50mm. The system includes instruments to facilitate the placement of the screws. FDA UDI
Identifiers
- Catalog Number
- CAPLOPROIMP FDA UDI
- Primary DI / UDI-DI
- 10381780064527 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™ 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 fcfa5c3c-ef21-4b19-94dd-50c06101dda2 37 fields · synced Jun 7, 2026