Osteonics Corp.
Mchenry, IL, US
Osteonics Corp. appears in FDA device records in Mchenry, IL. FDA records list 178 510(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
- 178
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 178FDA records hold 178 510(k) clearances for Osteonics Corp. between 1980 and 2000. The busiest year on record is 1998, with 26. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 1 |
| 1981 | 4 |
| 1983 | 3 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 7 |
| 1987 | 5 |
| 1988 | 6 |
| 1989 | 10 |
| 1990 | 7 |
| 1991 | 18 |
| 1992 | 9 |
| 1993 | 5 |
| 1994 | 10 |
| 1995 | 21 |
| 1996 | 10 |
| 1997 | 24 |
| 1998 | 26 |
| 1999 | 6 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | HRY | Substantially Equivalent | |
| K980070 | OSTEONICS HA-COATED DEVICES | MEH | Substantially Equivalent | |
| K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | KWP | Substantially Equivalent | |
| K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM | KWQ | Substantially Equivalent | |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | KWL | Substantially Equivalent | |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | MEH | Substantially Equivalent | |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | MNI | Substantially Equivalent | |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | MNH | Substantially Equivalent | |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | HSB | Substantially Equivalent | |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | LPH | Substantially Equivalent | |
| K983382 | OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM | MEH | Substantially Equivalent | |
| K983508 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM | HWC | Substantially Equivalent | |
| K983226 | OSTEONICS X CEMENTED HIP STEM SERIES | JDI | Substantially Equivalent | |
| K983165 | OSTEO 4.0MM CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K983870 | OSTEONICS RESTORATION HA HIP STEMS | MEH | Substantially Equivalent for Some Indications | |
| K983339 | OSTEO DYNATROC PROXIMAL FEMORAL NAIL | HSB | Substantially Equivalent | |
| K982936 | OSTEONICS EXTENDED FEMORAL BEARING HEAD | LWJ | Substantially Equivalent | |
| K983152 | OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS | MNH | Substantially Equivalent | |
| K982553 | OSTEO COMPRESSION HIP SCREW SYSTEM | HRS | Substantially Equivalent | |
| K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS | JDI | Substantially Equivalent | |
| K982601 | OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL | HSB | Substantially Equivalent | |
| K982032 | OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | MEH | Substantially Equivalent | |
| K981309 | OSTEO I-C HUMERAL NAIL SYSTEM | HSB | Substantially Equivalent | |
| K980766 | OSTEONICS ANTEVERTED NECK HA HIP STEMS | MEH | Substantially Equivalent | |
| K981452 | OSTEONICS LONG ARM CONTAINMENT RING | KWP | Substantially Equivalent | |
| K981259 | OSTEO 4.0MM CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K980594 | OSTEONICS FX-CABLELOK GRIP COMPONENTS | LYT | Substantially Equivalent | |
| K980502 | OSTEONICS TOTAL ELBOW SYSTEM | JDC | Substantially Equivalent | |
| K980774 | OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS | LZO | Substantially Equivalent | |
| K974807 | OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM | KWL | Substantially Equivalent | |
| K974556 | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K972967 | OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K974434 | OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS | HRY | Substantially Equivalent for Some Indications | |
| K973438 | OSTEO BOS SYSTEM PRODUCT LINE EXTENSION | HRS | Substantially Equivalent | |
| K973406 | OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K973204 | OSTEO BOS SYSTEM IN STAINLESS STEEL | HRS | Substantially Equivalent | |
| K972460 | OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) | JDI | Substantially Equivalent | |
| K972323 | OSTEO BOS SYSTEM | HRS | Substantially Equivalent | |
| K972196 | OSTEO ANATOMICAL BONE PLATES | HRS | Substantially Equivalent | |
| K971962 | OSTEO KIRSCHNER WIRES | HTY | Substantially Equivalent | |
| K971800 | OSTEO CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K971497 | OSTEONICS ANTEVERTED NECK HIP STEM | LZO | Substantially Equivalent | |
| K971654 | OSTEO COMPRESSION HIP SCREW SYSTEM | HWC | Substantially Equivalent | |
| K971409 | OSTEONICS ALUMINA C-TAPER HEAD | LZO | Substantially Equivalent | |
| K971321 | OSTEO COMPRESSION CONDYLE SCREW SYSTEM | HRS | Substantially Equivalent | |
| K971778 | OSTEO SMALL AND MINI BONE SCREWS | HWC | Substantially Equivalent | |
| K970957 | OSTEONICS RESTORATION ACETABULAR RING | JDJ | Substantially Equivalent | |
| K971422 | OSTEONICS ACETABULAR WEDGE SYSTEM | MEH | Substantially Equivalent for Some Indications | |
| K970779 | OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS | LZN | Substantially Equivalent | |
| K970697 | OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM | JDI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- LZNCement Obturator
- JDQCerclage, Fixation
- LYTFixation Accessory
- JDJMesh, Surgical, Acetabular, Hip, Prosthesis
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HTYPin, Fixation, Smooth
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- JDCProsthesis, Elbow, Constrained, Cemented
- JDKProsthesis, Hip, Cement Restrictor
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- KWAProsthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
- FWWTable, Operating-Room, Pneumatic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Osteonics Corp. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Osteonics Corp.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain