FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Argulated Locking Plates
K Number: K143338
·
Decision Apr 1, 2015
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
29
Review Days
132
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Basic Information
- Device Name
- Argulated Locking Plates
- K Number
- K143338
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteomed LP
- Date Received
- November 20, 2014
- Decision Date
- April 1, 2015
- Product Code
- JEY
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
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Other Clearances by Osteomed LP
| K Number | Device Name | ||
|---|---|---|---|
| K133691 | EXTRIMILOCK ANKLE PLATING SYSTEM | Feb 24, 2014 | Substantially Equivalent |
| K131445 | OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM | Jun 18, 2013 | 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 |