The following data is part of a premarket notification filed by Synthes Usa with the FDA for Synthes 2.7/3.5mm Variable Angle Lcp Ankle Trauma System-anterolateral Distal Tibia Plate.
| Device ID | K121601 |
| 510k Number | K121601 |
| Device Name: | SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES USA 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Angela F Lassandro |
| Correspondent | Angela F Lassandro SYNTHES USA 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 | 2012-06-01 |
| Decision Date | 2012-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679031181030 | K121601 | 000 |
| H67902118209S0 | K121601 | 000 |
| H679021182090 | K121601 | 000 |
| H67902118208S0 | K121601 | 000 |
| H679021182080 | K121601 | 000 |
| H67902118207S0 | K121601 | 000 |
| H679021182070 | K121601 | 000 |
| H67902118206S0 | K121601 | 000 |
| H679021182060 | K121601 | 000 |
| H67902118205S0 | K121601 | 000 |
| H679021182050 | K121601 | 000 |
| H67902118204S0 | K121601 | 000 |
| H679021182040 | K121601 | 000 |
| H67902118203S0 | K121601 | 000 |
| H679021182030 | K121601 | 000 |
| H67902118202S0 | K121601 | 000 |
| H679021182100 | K121601 | 000 |
| H67902118210S0 | K121601 | 000 |
| H679031181020 | K121601 | 000 |
| H67902118217S0 | K121601 | 000 |
| H679021182170 | K121601 | 000 |
| H67902118216S0 | K121601 | 000 |
| H679021182160 | K121601 | 000 |
| H67902118215S0 | K121601 | 000 |
| H679021182150 | K121601 | 000 |
| H67902118214S0 | K121601 | 000 |
| H679021182140 | K121601 | 000 |
| H67902118213S0 | K121601 | 000 |
| H679021182130 | K121601 | 000 |
| H67902118212S0 | K121601 | 000 |
| H679021182120 | K121601 | 000 |
| H67902118211S0 | K121601 | 000 |
| H679021182110 | K121601 | 000 |
| H679021182020 | K121601 | 000 |