Plate, Fixation, Bone, Non-Spinal, Metallic
The Plate, Fixation, Bone, Non-Spinal, Metallic (product code NDF) is a metallic orthopedic implant used to stabilize non-spinal bone fractures by bridging the fracture site and providing rigid fixation. It is an FDA Class 2 device within the Orthopedic specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant flag and is not designated as life-sustaining or GMP-exempt.
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Basic Information
- Product Code
- NDF
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K051642 | FR.O.H. CALCANEUS REPAIR SYSTEM | Aug 22, 2005 | Substantially Equivalent | I.T.S. Implantat-Technologie-Systeme GmbH |
| K021749 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | Aug 12, 2002 | Substantially Equivalent | Ebi, L.P. |
| K010551 | EBI DYNAFIX VS OSTEOTOMY SYSTEM | May 17, 2001 | Substantially Equivalent | Ebi, L.P. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.