FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
K Number: K141377
·
Decision Nov 21, 2014
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
530
Applicant Total
24
Review Days
178
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
- BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD
- K Number
- K141377
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3353
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merete Medical GmbH
- Date Received
- May 27, 2014
- Decision Date
- November 21, 2014
- Product Code
- LZO
- 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 |
|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZO), ordered by most recent decision date.
Z1 Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
Avenir® Müller Stem; Avenir Complete Hip System
FDA 510(k)
FDA Class 2
·Orthopedic
implantcast Packaging System Update
FDA 510(k)
FDA Class 2
·Orthopedic
implaFit® short stems
FDA 510(k)
FDA Class 2
·Orthopedic
Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)
FDA 510(k)
FDA Class 2
·Orthopedic
Coated hip implants
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Merete Medical GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K160548 | MC-Subtalar(TM) II | Apr 29, 2016 | Substantially Equivalent |
| K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws | Feb 12, 2016 | Substantially Equivalent |
| K151762 | PediatrOS RigidTack/FlexTack | Dec 28, 2015 | Substantially Equivalent |
| K142451 | OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod System | Feb 9, 2015 | Substantially Equivalent |
| K140069 | LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0 | Apr 7, 2014 | Substantially Equivalent |
| K132226 | METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT | Aug 9, 2013 | Substantially Equivalent |
| K123619 | INTRABLOCK BIOBALL HIP SYSTEM (IBS) | May 24, 2013 | Substantially Equivalent |
| K130400 | MERETEC CS, CORTICAL SCREWS | Apr 5, 2013 | Substantially Equivalent |
| K120787 | MERETE LOCKING BONE PLATE SYSTEM III | Nov 27, 2012 | Substantially Equivalent |
| K120978 | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR | May 2, 2012 | Substantially Equivalent |