Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (UDI Z-0453-2019)
Manufactured by Zimmer Biomet, Inc.
Device Regulatory Overview
The Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. (Model/Catalog Number: Unspecified) is a medical device manufactured by Zimmer Biomet, Inc.. This product is indexed under FDA Product Code / Category Classification Lot number 558260 558270 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter...
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, I...
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System...
Technical Specifications
- Model Number
- N/A
- Product Code / EMDN
- Lot number 558260 558270
- Device Name
- Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
- Database Sync Date
- 2026-08-09 10:06:36
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.?
The registered manufacturer of record for Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur. is Zimmer Biomet, Inc..
What is the Primary UDI-DI identifier for Affixus Hip Fracture Nail 130 Deg 10x165mm, Item Number 816810165 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0453-2019.
What classification code is assigned to this device?
This device is registered under product classification code Lot number 558260 558270.
Other Devices by Zimmer Biomet, Inc.
- → Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone
- → Persona Stemmed Tibial Provisional Size H Right, Item Number 42532108302 For use during orthopaedic surgery for implantation of a prosthesis.
- → Zimmer M/L Taper Hip Prosthesis With Kinective Technology Cementless, Size 12.5; 00-7713-012-00
- → XP-XP Tibial Tray - Interlok 75 mm Item # 195757
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint