FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
INHANCE Shoulder System, Sterile Single Use Instrumentation
K Number: K231516
·
Decision Jul 21, 2023
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
36
Applicant Total
48
Review Days
57
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Basic Information
- Device Name
- INHANCE Shoulder System, Sterile Single Use Instrumentation
- K Number
- K231516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3670
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Depuy Ireland UC
- Date Received
- May 25, 2023
- Decision Date
- July 21, 2023
- Product Code
- MBF
- 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 |
|---|---|---|---|
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | FDA class 2 | Orthopedic |
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