The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Lcp Pediatric Plate Systems.
| Device ID | K112085 |
| 510k Number | K112085 |
| Device Name: | SYNTHES LCP PEDIATRIC PLATE SYSTEMS |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Angela F Lassandro |
| Correspondent | Angela F Lassandro SYNTHES (USA) PRODUCTS LLC 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-21 |
| Decision Date | 2011-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902108422S0 | K112085 | 000 |
| H67902108341S0 | K112085 | 000 |
| H67902108340S0 | K112085 | 000 |
| H67902108333S0 | K112085 | 000 |
| H67902108332S0 | K112085 | 000 |
| H67902108331S0 | K112085 | 000 |
| H67902108330S0 | K112085 | 000 |
| H67902108326S0 | K112085 | 000 |
| H67902108316S0 | K112085 | 000 |
| H67902108303S0 | K112085 | 000 |
| H67902108301S0 | K112085 | 000 |
| H67902108342S0 | K112085 | 000 |
| H67902108343S0 | K112085 | 000 |
| H679021084100 | K112085 | 000 |
| H679021084220 | K112085 | 000 |
| H67902108421S0 | K112085 | 000 |
| H679021084210 | K112085 | 000 |
| H67902108420S0 | K112085 | 000 |
| H679021084200 | K112085 | 000 |
| H67902108412S0 | K112085 | 000 |
| H679021084120 | K112085 | 000 |
| H67902108411S0 | K112085 | 000 |
| H679021084110 | K112085 | 000 |
| H67902108410S0 | K112085 | 000 |
| H67902108300S0 | K112085 | 000 |