FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONE PLATE; BONE SCREW
K Number: K110926
·
Decision Dec 8, 2011
Classifications
1
FEI Numbers
106
Registration Numbers
106
Same Product Code
291
Applicant Total
5
Review Days
251
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Basic Information
- Device Name
- BONE PLATE; BONE SCREW
- K Number
- K110926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Biomaterials Korea, Inc.
- Date Received
- April 1, 2011
- Decision Date
- December 8, 2011
- 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 Biomaterials Korea, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222245 | ACR Screw System | Aug 21, 2023 | Substantially Equivalent |
| K173623 | Anchor plate | Aug 30, 2018 | Substantially Equivalent |
| K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | Sep 26, 2011 | Substantially Equivalent |
| K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Jul 26, 2007 | Substantially Equivalent |