Applied Osteo Systems, Inc.
Moraga, CA, US
Applied Osteo Systems, Inc. appears in FDA device records in Moraga, CA. FDA records list 15 510(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
- 15
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 15 510(k) clearances for Applied Osteo Systems, Inc. between 1990 and 1995. The busiest year on record is 1994, with 6. The most recent is 1995, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 4 |
| 1993 | 1 |
| 1994 | 6 |
| 1995 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K935383 | FEMROD AND FEMROD RECON INSERT | HSB | Substantially Equivalent | |
| K933995 | TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION | HSB | Substantially Equivalent | |
| K944501 | TRUE/FLEX INTRAMEDULLARY ROD END-CAP | HSB | Substantially Equivalent | |
| K941048 | TRUE/LOK MONOLATERAL/BILATERAL FIXATOR | LXT | Substantially Equivalent | |
| K943160 | INTERFERENCE SCREW | HWC | Substantially Equivalent for Some Indications | |
| K934148 | TRUE/FLEX CLAVICLE RODS | HSB | Substantially Equivalent | |
| K932853 | PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS | JEL | Substantially Equivalent | |
| K931578 | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR | JEC | Substantially Equivalent | |
| K926465 | FEMORAL INTRAMEDULLARY RODS | JDS | Substantially Equivalent | |
| K924657 | TRUE/FLEX METATARSAL RODS | KTW | Substantially Equivalent | |
| K924656 | TRUE/ FLEX FIBULA RODS | HSB | Substantially Equivalent | |
| K920598 | TRUE/FLEX HUMERUS CAP | HSB | Substantially Equivalent | |
| K913949 | TRUE/FLEX HUMERUS, ULNA & RADIUS INTRAMED RODS SYS | HSB | Substantially Equivalent | |
| K912710 | TRUE/FLEX TIBIAL RODS WITH CAP | HSB | Substantially Equivalent | |
| K902264 | TRUE/FLEX HUMERUS, ULNA AND RADIUS INTRAMEDULLARY | HSB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- KTWAppliance, Fixation, Nail/Blade/Plate Combination, Single Component
- JECComponent, Traction, Invasive
- JELCurette, Biopsy, Bronchoscope (Rigid)
- JDSNail, Fixation, Bone
- HSBRod, Fixation, Intramedullary And Accessories
- 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