FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ARROW Off-Centred Humeral Insert
K Number: K232226
·
Decision Aug 29, 2023
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
203
Applicant Total
9
Review Days
33
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Basic Information
- Device Name
- ARROW Off-Centred Humeral Insert
- K Number
- K232226
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FH Industrie
- Date Received
- July 27, 2023
- Decision Date
- August 29, 2023
- Product Code
- PHX
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | FDA class 2 | Orthopedic |
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Other Clearances by FH Industrie
| K Number | Device Name | ||
|---|---|---|---|
| K254003 | JARVIS Metaphyseal Stem | Jan 9, 2026 | Substantially Equivalent |
| K253345 | JARVIS Diaphyseal Stem Standard | Oct 29, 2025 | Substantially Equivalent |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | Aug 28, 2025 | Substantially Equivalent |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | Nov 25, 2024 | Substantially Equivalent |
| K220758 | e-Ortho Shoulder Software v1.1 | Sep 30, 2022 | Substantially Equivalent |
| K202024 | ARROW Short Stem Humeral System | Nov 30, 2021 | Substantially Equivalent |
| K200127 | TELEGRAPH® EVOLUTION Humeral Nailing System | Oct 1, 2020 | Substantially Equivalent |
| K201928 | e-Ortho Shoulder Software | Sep 30, 2020 | Substantially Equivalent |