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Responsive Orthopedics Total Knee Arthroplasty System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Responsive Orthopedics Total Knee Arthroplasty System FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- TOOL 90-SRK-100010 POLY REMOVAL FDA UDI
- Model / Reference
- 90-SRK-100010 FDA UDI
- Description
- TOOL 90-SRK-100010 POLY REMOVAL FDA UDI
Identifiers
- Catalog Number
- 90-SRK-100010 FDA UDI
- Primary DI / UDI-DI
- 00841973106166 FDA UDI
- FDA Product Code
- JWH FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, reusable
Responsive Orthopedics Total Knee Arthroplasty System by Responsive Orthopedics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.
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- Vu ePOD™ — SeaSpine Orthopedics Corporation · Class II
- Mariner MCT — SeaSpine Orthopedics Corporation · Class II
- PEEK Corpectomy — Nuvasive, Inc. · Class II
- TIMBERLINE LATERAL FUSION SYSTEM — BIOMET SPINE LLC · Class II
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
- Responsive Orthopedics Llc
Sources (1)
- FDA UDI c8f8c174-fe99-49f9-a178-4a5e8fe8dd1d 34 fields · synced Jun 8, 2026