The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for I.t.s. Lrs Locking Reconstruction System.
| Device ID | K093868 |
| 510k Number | K093868 |
| Device Name: | I.T.S. LRS LOCKING RECONSTRUCTION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Contact | Al Lippincott |
| Correspondent | Al Lippincott I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH 3150 E. 200TH ST. Prior Lake, MN 55372 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-17 |
| Decision Date | 2010-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120047307328 | K093868 | 000 |
| 09120034307119 | K093868 | 000 |
| 09120034307102 | K093868 | 000 |
| 09120034307096 | K093868 | 000 |
| 09120034307089 | K093868 | 000 |
| 09120034307072 | K093868 | 000 |
| 09120034307065 | K093868 | 000 |
| 09120034307058 | K093868 | 000 |
| 09120034307041 | K093868 | 000 |
| 09120034307126 | K093868 | 000 |
| 09120034307133 | K093868 | 000 |
| 09120047307311 | K093868 | 000 |
| 09120047300305 | K093868 | 000 |
| 09120047300299 | K093868 | 000 |
| 09120047299838 | K093868 | 000 |
| 09120047299821 | K093868 | 000 |
| 09120034309311 | K093868 | 000 |
| 09120034309304 | K093868 | 000 |
| 09120034307140 | K093868 | 000 |
| 09120034307034 | K093868 | 000 |