The following data is part of a premarket notification filed by Synthes (usa) Llc with the FDA for 2.7/3.5mm Va-lcp Anteriro Clavicle Plate System.
| Device ID | K101536 |
| 510k Number | K101536 |
| Device Name: | 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Lisa Graney |
| Correspondent | Lisa Graney SYNTHES (USA) LLC 1301 Goshen Parkway 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 | 2010-06-03 |
| Decision Date | 2010-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902112049S0 | K101536 | 000 |
| H67904112049S0 | K101536 | 000 |
| H67904112048S0 | K101536 | 000 |
| H67904112047S0 | K101536 | 000 |
| H679041120470 | K101536 | 000 |
| H67904112046S0 | K101536 | 000 |
| H679041120460 | K101536 | 000 |
| H67904112045S0 | K101536 | 000 |
| H679041120450 | K101536 | 000 |
| H67904112042S0 | K101536 | 000 |
| H679041120420 | K101536 | 000 |
| H67904112041S0 | K101536 | 000 |
| H679041120410 | K101536 | 000 |
| H67904112040S0 | K101536 | 000 |
| H679021120400 | K101536 | 000 |
| H67902112040S0 | K101536 | 000 |
| H679021120490 | K101536 | 000 |
| H67902112048S0 | K101536 | 000 |
| H679021120480 | K101536 | 000 |
| H67902112047S0 | K101536 | 000 |
| H679021120470 | K101536 | 000 |
| H67902112046S0 | K101536 | 000 |
| H679021120460 | K101536 | 000 |
| H67902112045S0 | K101536 | 000 |
| H679021120450 | K101536 | 000 |
| H67902112042S0 | K101536 | 000 |
| H679021120420 | K101536 | 000 |
| H67902112041S0 | K101536 | 000 |
| H679021120410 | K101536 | 000 |
| H679041120400 | K101536 | 000 |