FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
EBI ANTERIOR CERVICAL PLATE SYSTEM
K Number: K001794
·
Decision Jul 12, 2000
Classifications
1
FEI Numbers
356
Registration Numbers
356
Same Product Code
665
Applicant Total
95
Review Days
28
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Basic Information
- Device Name
- EBI ANTERIOR CERVICAL PLATE SYSTEM
- K Number
- K001794
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Ebi, L.P.
- Date Received
- June 14, 2000
- Decision Date
- July 12, 2000
- Product Code
- KWQ
- 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 |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
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Other Clearances by Ebi, L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K100438 | POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTURE ANTERIOR FIXATION SYSTEM | Jun 23, 2010 | Substantially Equivalent |
| K100220 | POLARIS SPINAL SYSTEM | May 17, 2010 | Substantially Equivalent |
| K093880 | PEANUT GROWTH CONTROL PLATING SYSTEM | Apr 16, 2010 | Substantially Equivalent |
| K092574 | ESL SPINAL SYSTEM | Feb 4, 2010 | Substantially Equivalent |
| K093057 | BIOMET VISION FOOTRING SYSTEM | Dec 1, 2009 | Substantially Equivalent |
| K092336 | C-THRU SPINAL SYSTEM | Oct 15, 2009 | Substantially Equivalent |
| K091381 | IBEX SPINAL SYSTEM | Aug 7, 2009 | Substantially Equivalent |
| K090203 | 5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS | Jul 30, 2009 | Substantially Equivalent |
| K090523 | POLARIS SPINAL SYSTEM | Jul 1, 2009 | Substantially Equivalent |
| K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT | Jan 14, 2009 | Substantially Equivalent |