FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HydroSet XT
K Number: K161447
·
Decision Oct 6, 2016
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
491
Applicant Total
23
Review Days
134
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
- HydroSet XT
- K Number
- K161447
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3045
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Orthovita, Inc.
- Date Received
- May 25, 2016
- Decision Date
- October 6, 2016
- Product Code
- MQV
- 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 |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQV), ordered by most recent decision date.
Device 300419 Strip
FDA 510(k)
FDA Class 2
·Orthopedic
JAZBI Resorbable Bone Void Filler
FDA 510(k)
FDA Class 2
·Orthopedic
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive Bone Graft Substitute; Vitoss BBTrauma® Bioactive Bone Graft Substitute; Vitoss® BA2X Bioactive Bone Graft Substitute; Vitoss® Bioactive Foam Bone Graft Substitute Pack; Vitoss® Bioactive Foam Bone Graft Substitute; Vitoss® Foam Bone Graft Substitute; Vitoss® Bone Graft Substitute Filled Canister; Vitoss® Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
Adaptos®Fuse Bone Graft
FDA 510(k)
FDA Class 2
·Orthopedic
FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft Substitute FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute FIBERGRAFT BG Matrix Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETE
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Orthovita, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K163621 | Vitoss Bioactive (BA) Injectable | May 2, 2017 | Substantially Equivalent |
| K153608 | Vitoss BiModal Bone Graft Substitute Foam Strip | Feb 12, 2016 | Substantially Equivalent |
| K153306 | Imbibe Needle | Dec 18, 2015 | Substantially Equivalent |
| K140868 | STRYKER KWIC NEEDLE | Jun 5, 2014 | Substantially Equivalent |
| K140414 | IMBIBE NEEDLE | Apr 1, 2014 | Substantially Equivalent |
| K103173 | VITOSS BA BIMODAL BIOACTIVE BONE GRAFT SUBSTITUTE | Feb 7, 2011 | Substantially Equivalent |
| K101171 | ORTHOVITA PEEK SPACER | Jan 25, 2011 | Substantially Equivalent |
| K102545 | FM-02 BONE GRAFT SUBSTITUTE | Oct 27, 2010 | Substantially Equivalent |
| K091618 | VITOMATRIX | Sep 27, 2010 | Substantially Equivalent |
| K080108 | CORTOSS BONE AUGMENTATION MATERIAL | Jun 5, 2009 | Substantially Equivalent |