The following data is part of a premarket notification filed by Citieffe with the FDA for External Fixator St.a R 90 F4.
| Device ID | K113384 |
| 510k Number | K113384 |
| Device Name: | EXTERNAL FIXATOR ST.A R 90 F4 |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | CITIEFFE 110 E. GRANADA BLVD. SUITE 209 Ormond Beach, FL 32176 |
| Contact | Claude Berthoin |
| Correspondent | Claude Berthoin CITIEFFE 110 E. GRANADA BLVD. SUITE 209 Ormond Beach, FL 32176 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051739535334 | K113384 | 000 |
| 08032909624294 | K113384 | 000 |
| 08032909624300 | K113384 | 000 |
| 08032909624324 | K113384 | 000 |
| 08032909624331 | K113384 | 000 |
| 08032909624348 | K113384 | 000 |
| 08032909624386 | K113384 | 000 |
| 08032909624393 | K113384 | 000 |
| 08032909624409 | K113384 | 000 |
| 08032909629954 | K113384 | 000 |
| 08032909629930 | K113384 | 000 |
| 08052990971855 | K113384 | 000 |
| 08032909623747 | K113384 | 000 |
| 08051739536218 | K113384 | 000 |
| 08051739536225 | K113384 | 000 |
| 08032909623730 | K113384 | 000 |
| 08051739535822 | K113384 | 000 |
| 08032909624287 | K113384 | 000 |