Electro-Biology, Inc.
Mchenry, IL, US
Electro-Biology, Inc. appears in FDA device records in Mchenry, IL. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Electro-Biology, Inc. between 1983 and 1999. The busiest year on record is 1999, with 8. The most recent is 1999, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1994 | 1 |
| 1995 | 6 |
| 1996 | 3 |
| 1997 | 4 |
| 1998 | 3 |
| 1999 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K992333 | EBI OMEGA 21 SYSTEM | MNI | Substantially Equivalent | |
| K992367 | EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS | HWC | Substantially Equivalent | |
| K991941 | EBI XFIX DFS RAIL SYSTEM | KTT | Substantially Equivalent | |
| K991092 | EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM | KWQ | Substantially Equivalent | |
| K990303 | EBI OMEGA 21 SYSTEM | KWP | Substantially Equivalent | |
| K990459 | EBI VUECATH ENDOSCOPIC SYSTEN | HRX | Substantially Equivalent | |
| K990999 | MODIFICATION OF: EBI SPINELINK SYSTEM | MAI | Substantially Equivalent | |
| K984027 | EBI SPINELINK SYSTEM | MNI | Substantially Equivalent | |
| K982484 | EBI VUECATH ENDOSCOPIC SPINAL SYSTEM | HRX | Substantially Equivalent | |
| K982908 | MODIFICATION TO EBI SPINELINK SYSTEM | KWP | Substantially Equivalent | |
| K981483 | EBI DFS JOINT FIXATOR, MODEL 02800 | KTT | Substantially Equivalent | |
| K971970 | EBI SPINELINK SYSTEM | MNH | Substantially Equivalent | |
| K971083 | ARTHROSCOPE | HRX | Substantially Equivalent | |
| K964797 | EBI SPINELINK SYSTEM | KWQ | Substantially Equivalent | |
| K964533 | EBI SPINELINK SYSTEM | MNH | Substantially Equivalent | |
| K963261 | EBI THERMAL THERAPY SYSTEM | ILO | Substantially Equivalent | |
| K961433 | EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS | KTT | Substantially Equivalent for Some Indications | |
| K955730 | EBI ANTERIOR CERVICAL SPINE SYSTEM | KWQ | Substantially Equivalent for Some Indications | |
| K953406 | EBI X FIX DYNAFIX SYSTEM (DFS) | KTT | Substantially Equivalent | |
| K953532 | EBICE | ILO | Substantially Equivalent | |
| K945781 | WEBB-MORLEY SPINE SYSTEM | KWP | Substantially Equivalent | |
| K951357 | EBI SMALL EXTERNAL FIXATOR (S/E/F/) | KTT | Substantially Equivalent for Some Indications | |
| K945067 | EBICE | ILO | Substantially Equivalent for Some Indications | |
| K943694 | EBI ANTERIOR CERVICAL SPINE SYSTEM | KWQ | Substantially Equivalent for Some Indications | |
| K941367 | WEBB-MORLEY SPINE SYSTEM | KWQ | Substantially Equivalent for Some Indications | |
| K860632 | EBI HAND MASSAGING PUMP (HMP) | IRP | Substantially Equivalent | |
| K852264 | EBI FOOT MASSAGING PUMP | IRP | Substantially Equivalent | |
| K831576 | ORTHOFIX | JEC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- JECComponent, Traction, Invasive
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- IRPMassager, Powered Inflatable Tube
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- ILOPack, Hot Or Cold, Water Circulating
- HWCScrew, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain