The following data is part of a premarket notification filed by I.t.s. Implantat-technologie-systeme Gmbh with the FDA for Pilonplate With Angular Stability.
| Device ID | K052011 |
| 510k Number | K052011 |
| Device Name: | PILONPLATE WITH ANGULAR STABILITY |
| 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 | 2005-07-25 |
| Decision Date | 2005-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09120047299814 | K052011 | 000 |
| 09120034309984 | K052011 | 000 |
| 09120034304996 | K052011 | 000 |
| 09120034303111 | K052011 | 000 |
| 09120047298008 | K052011 | 000 |
| 09120047297995 | K052011 | 000 |
| 09120047297971 | K052011 | 000 |
| 09120034305009 | K052011 | 000 |
| 09120034304989 | K052011 | 000 |
| 09120034303128 | K052011 | 000 |
| 09120034309991 | K052011 | 000 |
| 09120047290019 | K052011 | 000 |
| 09120047299807 | K052011 | 000 |
| 09120047299791 | K052011 | 000 |
| 09120047299784 | K052011 | 000 |
| 09120047297988 | K052011 | 000 |
| 09120047296844 | K052011 | 000 |
| 09120047296837 | K052011 | 000 |
| 09120047290064 | K052011 | 000 |
| 09120047290057 | K052011 | 000 |
| 09120047290040 | K052011 | 000 |
| 09120034303104 | K052011 | 000 |