The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 2.4/2.7 Mm Locking Foot Module.
| Device ID | K071264 |
| 510k Number | K071264 |
| Device Name: | SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Deborah L Jackson |
| Correspondent | Deborah L Jackson 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 | 2007-05-04 |
| Decision Date | 2007-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H67902100023S0 | K071264 | 000 |
| H6792477020 | K071264 | 000 |
| H67904100023S0 | K071264 | 000 |
| H67904100022S0 | K071264 | 000 |
| H67904100021S0 | K071264 | 000 |
| H67904100020S0 | K071264 | 000 |
| H679449691S0 | K071264 | 000 |
| H679449690S0 | K071264 | 000 |
| H679447711S0 | K071264 | 000 |
| H6794477110 | K071264 | 000 |
| H679447710S0 | K071264 | 000 |
| H6794477100 | K071264 | 000 |
| H679447706S0 | K071264 | 000 |
| H6794477060 | K071264 | 000 |
| H679447704S0 | K071264 | 000 |
| H6794477040 | K071264 | 000 |
| H679447702S0 | K071264 | 000 |
| H679247702S0 | K071264 | 000 |
| H6792477040 | K071264 | 000 |
| H67902100022S0 | K071264 | 000 |
| H67902100021S0 | K071264 | 000 |
| H67902100020S0 | K071264 | 000 |
| H6794496910 | K071264 | 000 |
| H6794496900 | K071264 | 000 |
| H679249691S0 | K071264 | 000 |
| H6792496910 | K071264 | 000 |
| H679249690S0 | K071264 | 000 |
| H6792496900 | K071264 | 000 |
| H679247711S0 | K071264 | 000 |
| H6792477110 | K071264 | 000 |
| H679247710S0 | K071264 | 000 |
| H6792477100 | K071264 | 000 |
| H679247706S0 | K071264 | 000 |
| H6792477060 | K071264 | 000 |
| H679247704S0 | K071264 | 000 |
| H6794477020 | K071264 | 000 |