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 |