FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
K Number: K131445
·
Decision Jun 18, 2013
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
29
Review Days
29
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Basic Information
- Device Name
- OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
- K Number
- K131445
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- May 20, 2013
- Decision Date
- June 18, 2013
- 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
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
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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Other Clearances by Osteomed LP
| K Number | Device Name | ||
|---|---|---|---|
| K143338 | Argulated Locking Plates | Apr 1, 2015 | Substantially Equivalent |
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | Feb 24, 2014 | Substantially Equivalent |
| K123885 | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Jun 3, 2013 | Substantially Equivalent |
| K123207 | PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM | Nov 29, 2012 | Substantially Equivalent |
| K120015 | OSTEOMED WRIST PLATING SYSTEM | Apr 24, 2012 | Substantially Equivalent |
| K111419 | OSTEOMED HAND FUSION SYSTEM | Oct 7, 2011 | Substantially Equivalent |
| K111176 | OSTEOMED LOW PROFILE NEURO FIXATION SYSTEM | Aug 15, 2011 | Substantially Equivalent |
| K102438 | PRIMALOK FACET FIXATION SYSTEM | Sep 30, 2010 | Substantially Equivalent |
| K100354 | PRIMAL OK INTERSPINOUS FUSION SYSTEM | Aug 17, 2010 | Substantially Equivalent |
| K091614 | OSTEOMED FOOT PLATING SYSTEM | Sep 10, 2009 | Substantially Equivalent |