FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OVOMotion Shoulder Arthroplasty System
K Number: K173964
·
Decision Apr 18, 2018
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
70
Applicant Total
26
Review Days
110
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Basic Information
- Device Name
- OVOMotion Shoulder Arthroplasty System
- K Number
- K173964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3690
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Arthrosurface, Inc.
- Date Received
- December 29, 2017
- Decision Date
- April 18, 2018
- Product Code
- HSD
- 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 |
|---|---|---|---|
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | FDA class 2 | Orthopedic |
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Other Clearances by Arthrosurface, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K203375 | OVOMotion Reverse Shoulder Arthroplasty System | Jun 24, 2021 | Substantially Equivalent |
| K200718 | Arthrosurface WristMotion Total Wrist Arthroplasty System | Oct 15, 2020 | Substantially Equivalent |
| K190261 | BOSS Toe Fixation System | Aug 14, 2019 | Substantially Equivalent |
| K181280 | Patello-Femoral Wave (Kahuna) Arthroplasty System | Jun 14, 2018 | Substantially Equivalent |
| K172383 | Arthrosurface Bone Screws | Dec 22, 2017 | Substantially Equivalent |
| K170440 | KISSloc Suture System | May 3, 2017 | Substantially Equivalent |
| K170350 | ToeMATE® Hammertoe Correction System | Mar 3, 2017 | Substantially Equivalent |
| K162391 | AlignMATE Lapidus Arthrodesis System | Feb 21, 2017 | Substantially Equivalent |
| K161539 | Arthrosurface Bone Screws | Jun 30, 2016 | Substantially Equivalent |
| K152454 | HemiCAP MTP Resurfacing Hemi-Arthroplasty System | Apr 11, 2016 | Substantially Equivalent |