FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
K Number: K042321
·
Decision Jan 28, 2005
Classifications
1
FEI Numbers
155
Registration Numbers
155
Same Product Code
70
Applicant Total
93
Review Days
155
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD
- K Number
- K042321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3650
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet Manufacturing Corp
- Date Received
- August 26, 2004
- Decision Date
- January 28, 2005
- Product Code
- KWT
- 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 |
|---|---|---|---|
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KWT), ordered by most recent decision date.
Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants
FDA 510(k)
FDA Class 2
·Orthopedic
Tornier Humeral Reconstruction System Max (Tornier HRS Max)
FDA 510(k)
FDA Class 2
·Orthopedic
AGILON® XO Shoulder Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
InSet Total Shoulder System
FDA 510(k)
FDA Class 2
·Orthopedic
AGILON® XO Shoulder Replacement System
FDA 510(k)
FDA Class 2
·Orthopedic
Comprehensive Segmental Revision System(SRS)
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Biomet Manufacturing Corp
| K Number | Device Name | ||
|---|---|---|---|
| K230540 | Patient Specific Planning Solution 3D Bone Models | Jul 25, 2023 | Substantially Equivalent |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | Mar 15, 2023 | Substantially Equivalent |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Nov 4, 2021 | Substantially Equivalent |
| K202232 | Comprehensive Vault Reconstruction System | Feb 19, 2021 | Substantially Equivalent |
| K193038 | Comprehensive Shoulder System | Oct 28, 2020 | Substantially Equivalent |
| K182516 | Comprehensive Nano Stemless Shoulder | Apr 22, 2019 | Substantially Equivalent |
| K181611 | Comprehensive Reverse Shoulder System | Sep 24, 2018 | Substantially Equivalent |
| K173411 | Comprehensive Segmental Revision System (SRS) | Feb 8, 2018 | Substantially Equivalent |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | Jan 3, 2018 | Substantially Equivalent |
| K163651 | ExpressBraid Graft Manipulation | Feb 17, 2017 | Substantially Equivalent |