I.T.S. Implantat-Technologie-Systeme GmbH
Prior Lake, MN, US
I.T.S. Implantat-Technologie-Systeme GmbH appears in FDA device records in Prior Lake, MN. FDA records list 13 510(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
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for I.T.S. Implantat-Technologie-Systeme GmbH between 2004 and 2010. The busiest year on record is 2005, with 6. The most recent is 2010, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2005 | 6 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 2 |
| 2010 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K093868 | I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM | HRS | Substantially Equivalent | |
| K080706 | CONNEXX LOCKING TIBIA NAIL | JDS | Substantially Equivalent | |
| K080184 | DISTAL HUMERAL PLATES WITH ANGULAR STABILITY | HRS | Substantially Equivalent | |
| K063672 | FIBULA PLATE PROLOCK WITH ANGULAR STABILITY | HRS | Substantially Equivalent | |
| K063166 | I.T.S. PELVIC RECONSTRUCTION SYSTEM | HRS | Substantially Equivalent | |
| K060156 | STRAIGHT PLATE WITH ANGULAR STABILITY & SCREW SYSTEM | HRS | Substantially Equivalent | |
| K052368 | OLECRANONPLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | |
| K051642 | FR.O.H. CALCANEUS REPAIR SYSTEM | NDF | Substantially Equivalent | |
| K052011 | PILONPLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | |
| K051412 | HUMERAL HEAD PLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent | |
| K050852 | CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM | HRS | Substantially Equivalent | |
| K043410 | EPIPHYSIS SCREW | HWC | Substantially Equivalent | |
| K033756 | VOLAR RADIUS PLATE WITH ANGULAR STABILITY | HRS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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