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Paragon28 JAWS™ Nitinol Staple System - HSA Registration DE0507023

Access comprehensive regulatory information for Paragon28 JAWS™ Nitinol Staple System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0507023 and owned by Paragon 28, Inc. The device was registered on June 28, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS C
DE0507023
Paragon28 JAWS™ Nitinol Staple System
HSA Registration Number: DE0507023
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Product Description

The JAWS™ Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0507023
Registration Date
June 28, 2022
Retention Due Date
June 27, 2025
Product Owner
Short Name
Paragon 28, Inc
Address
14445 Grasslands Drive, Englewood, Colorado, 80112, UNITED STATES
Registrant
Address
8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305
Importer
Address
8 JALAN KILANG TIMOR, KEWALRAM HOUSE, #03-04A, SINGAPORE 159305
Model Information
Model Name(s)
Akin Staple, 8mm, 8x8 Straight Akin Staple, 10mm, 10x10 Straight Jaws, Akin Staple, 15mm, 15x15 Straight Jaws, Akin Staple, 18mm, 18x18 Straight Jaws, Akin Staple, 20mm, 20x20 Straight JAWS Staple System, 25x20x20mm Staple Akin Staple, 8mm, 8x8 Angled Akin Staple, 10mm, 10x10 Angled K-Wire, 1.6mm, 100mm Locating Pin, 1.4mm, 50mm JAWS, Locating Pin, 2.3mm, 90mm JAWS, Locating Pin, 2.3mm, 90mm Staple Inserter, 8mm, Straight Staple Inserter, 10mm, Straight JAWS, Staple Inserter, 15mm, Straight JAWS, Staple Inserter, 18mm, Straight JAWS, Staple Inserter, 20mm, Straight JAWS Staple System, Inserter, Straight, 25mm Staple Inserter, 8mm, Angled Staple Inserter, 10mm, Angled Staple Kit, 8mm Straight, Sterile Staple Kit, 10mm Straight, Sterile Staple Kit, 15mm Straight, Sterile Staple Kit, 18mm Straight, Sterile Staple Kit, 20mm Straight, Sterile Staple Kit, 25mm Straight, Sterile Staple Kit, 8mm Angled, Sterile Staple Kit, 10mm Angled, Sterile 2.3 x 85 mm Drill, Solid, AO 2.7 x 85 mm Drill, Solid, AO P28, K-Wire, 1.6 x 150 mm, Single Trocar, Smooth, SS P28, K-Wire, 2.0 x 150 mm, Smooth SS
Model Identifier(s)
P70-008-0808 P70-010-1010 P70-015-1515 P70-018-1818 P70-020-2020 P70-025-2020 P70-108-0808 P70-110-1010 P70-192-1610 P70-293-1405 P70-293-2309 P70-293-2709 P70-911-0008 P70-911-0010 P70-911-0015 P70-911-0018 P70-911-0020 P70-911-0025 P70-912-0008 P70-912-0010 P71-008-0808-S P71-010-1010-S P71-015-1515-S P71-018-1818-S P71-020-2020-S P71-025-2020-S P71-108-0808-S P71-110-1010-S P99-100-2309 P99-100-2709 P99-192-1615 P99-192-2015