FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EBI OMEGA 21 SYSTEM
K Number: K990303
·
Decision Apr 29, 1999
Classifications
1
FEI Numbers
321
Registration Numbers
321
Same Product Code
429
Applicant Total
28
Review Days
87
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Basic Information
- Device Name
- EBI OMEGA 21 SYSTEM
- K Number
- K990303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3050
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro-Biology, Inc.
- Date Received
- February 1, 1999
- Decision Date
- April 29, 1999
- Product Code
- KWP
- 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 |
|---|---|---|---|
| KWP | Appliance, Fixation, Spinal Interlaminal | FDA class 2 | Orthopedic |
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Other Clearances by Electro-Biology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992333 | EBI OMEGA 21 SYSTEM | Oct 8, 1999 | Substantially Equivalent |
| K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS | Sep 23, 1999 | Substantially Equivalent |
| K991941 | EBI XFIX DFS RAIL SYSTEM | Aug 19, 1999 | Substantially Equivalent |
| K991092 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Apr 29, 1999 | Substantially Equivalent |
| K990459 | EBI VUECATH ENDOSCOPIC SYSTEN | Apr 23, 1999 | Substantially Equivalent |
| K990999 | MODIFICATION OF: EBI SPINELINK SYSTEM | Apr 14, 1999 | Substantially Equivalent |
| K984027 | EBI SPINELINK SYSTEM | Jan 19, 1999 | Substantially Equivalent |
| K982484 | EBI VUECATH ENDOSCOPIC SPINAL SYSTEM | Oct 8, 1998 | Substantially Equivalent |
| K982908 | MODIFICATION TO EBI SPINELINK SYSTEM | Aug 28, 1998 | Substantially Equivalent |
| K981483 | EBI DFS JOINT FIXATOR, MODEL 02800 | Jul 8, 1998 | Substantially Equivalent |