FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AltiVate Reverse Humeral Stem, 48mm
K Number: K190290
·
Decision Apr 26, 2019
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
189
Applicant Total
81
Review Days
74
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Basic Information
- Device Name
- AltiVate Reverse Humeral Stem, 48mm
- K Number
- K190290
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3660
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encore Medical L.P.
- Date Received
- February 11, 2019
- Decision Date
- April 26, 2019
- Product Code
- KWS
- 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 |
|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
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Other Clearances by Encore Medical L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K252567 | AltiVate Reverse® ADLC Glenosphere | Jan 15, 2026 | Substantially Equivalent |
| K252974 | EMPOWR Knee | Dec 19, 2025 | Substantially Equivalent |
| K251833 | EMPOWR Acetabular® Liner Extension | Nov 12, 2025 | Substantially Equivalent |
| K252141 | AltiVate Reverse® Glenoid | Aug 5, 2025 | Substantially Equivalent |
| K251776 | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | Jul 8, 2025 | Substantially Equivalent |
| K251241 | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | Jul 2, 2025 | Substantially Equivalent |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR Shoulder System; PRIMA Humeral System; PRIMA Glenoid System | May 16, 2025 | Substantially Equivalent |
| K241483 | ceramys femoral head system | Feb 7, 2025 | Substantially Equivalent |
| K233481 | AltiVate Reverse® Glenoid | May 29, 2024 | Substantially Equivalent |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with Markers | Jun 23, 2023 | Substantially Equivalent |