FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MERETE LOCKING BONE PLATE SYSTEM III
K Number: K120787
·
Decision Nov 27, 2012
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
24
Review Days
257
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Basic Information
- Device Name
- MERETE LOCKING BONE PLATE SYSTEM III
- K Number
- K120787
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merete Medical GmbH
- Date Received
- March 15, 2012
- Decision Date
- November 27, 2012
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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|---|---|---|---|
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| K141377 | BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD | Nov 21, 2014 | 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 |
| K120978 | OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR | May 2, 2012 | Substantially Equivalent |