Unspecified Brand (UDI 00192629096950)
Manufactured by MicroPort Orthopedics Inc.
Device Regulatory Overview
The Unspecified Brand (Model/Catalog Number: PRGLCLE9) is a medical device manufactured by MicroPort Orthopedics Inc.. This product is indexed under FDA Product Code / Category Classification P090804010202 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product De...
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 L...
EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only....
Technical Specifications
- Model Number
- PRGLCLE9
- Product Code / EMDN
- P090804010202
- Device Name
- Profemur Gladiator Plasma Classic Stem
- Database Sync Date
- 2026-08-09 16:28:47
Full Regulatory Attributes
π Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Unspecified Brand?
The registered manufacturer of record for Unspecified Brand is MicroPort Orthopedics Inc..
What is the Primary UDI-DI identifier for Unspecified Brand?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00192629096950.
What classification code is assigned to this device?
This device is registered under product classification code P090804010202.
Similar Classification Devices (P090804010202)
Other Devices by MicroPort Orthopedics Inc.
- β Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
- β EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
- β EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
- β ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
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