Orthopedic Sciences, Inc
Overland Park, KS, US
ORTHOPEDIC SCIENCES, INC appears in FDA device records in Overland Park, KS. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Orthopedic Sciences, Inc between 2002 and 2014. The busiest year on record is 2005, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2004 | 2 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2009 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133018 | OSI Q SYSTEM ARTHROSCOPES | HRX | Substantially Equivalent | |
| K091398 | ARTHROSCOPE | HRX | Substantially Equivalent | |
| K072175 | TITANIUM HIP TOOL LOCKING PLATE | HRS | Substantially Equivalent | |
| K063709 | TS-BONE HIP TOOL | HRS | Substantially Equivalent | |
| K063033 | MODIFICATION TO TITANIUM SHOULDER PLATE IMPLANT | HRS | Substantially Equivalent | |
| K052538 | S-BONE HIP TOOL | HRS | Substantially Equivalent | |
| K051181 | CUSTOM-HIP TOOL | HRS | Substantially Equivalent | |
| K051032 | TITANIUM-HIP TOOL | HRS | Substantially Equivalent | |
| K040493 | OUTOLOGOUS SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent | |
| K040850 | TSY SHOULDER PLATE IMPLANT | HRS | Substantially Equivalent | |
| K022139 | HIP TOOL IMPLANT | HRS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2032830 | 3004167986 | ORTHOPEDIC SCIENCES, INC | 6600 College Blvd Ste 138, Overland Park, KS 66211 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NBHAccessories, Arthroscopic
- HRXArthroscope
- HTWBit, Drill
- GFABlade, Saw, General & Plastic Surgery, Surgical
- GFFBur, Surgical, General & Plastic Surgery
- HTTBurr, Orthopedic
- JOLCatheter And Tip, Suction
- HTFCurette
- MAIFastener, Fixation, Biodegradable, Soft Tissue
- GDFGuide, Needle, Surgical
- HWAImpactor
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- HXIPasser, Wire, Orthopedic
- HRSPlate, Fixation, Bone
- HXXScrewdriver
- PPRSurgical Cannulaes & Depth Gauge Kit For Arthroscopic Procedures
- FSMTray, Surgical, Instrument
- HWKTrephine
- GAZTubing, Noninvasive
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