FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EBI XFIX DFS RAIL SYSTEM
K Number: K991941
·
Decision Aug 19, 1999
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
28
Review Days
71
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Basic Information
- Device Name
- EBI XFIX DFS RAIL SYSTEM
- K Number
- K991941
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electro-Biology, Inc.
- Date Received
- June 9, 1999
- Decision Date
- August 19, 1999
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 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 |
| K991092 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | Apr 29, 1999 | Substantially Equivalent |
| K990303 | EBI OMEGA 21 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 |