The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for Embrace Thermoplastic.
| Device ID | K120335 |
| 510k Number | K120335 |
| Device Name: | EMBRACE THERMOPLASTIC |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner M.d., Ph.d. |
| Correspondent | James Huttner M.d., Ph.d. BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-03 |
| Decision Date | 2012-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817740021045 | K120335 | 000 |
| 10817740020277 | K120335 | 000 |
| 10817740020260 | K120335 | 000 |
| 10817740020253 | K120335 | 000 |
| 10817740020246 | K120335 | 000 |
| 10817740020239 | K120335 | 000 |
| 10817740020222 | K120335 | 000 |
| 10817740020215 | K120335 | 000 |
| 10817740020208 | K120335 | 000 |
| 10817740020192 | K120335 | 000 |
| 10817740020185 | K120335 | 000 |
| 10817740020178 | K120335 | 000 |
| 10817740020161 | K120335 | 000 |
| 10817740020154 | K120335 | 000 |
| 10817740020284 | K120335 | 000 |
| 10817740020291 | K120335 | 000 |
| 10817740020420 | K120335 | 000 |
| 00817740020416 | K120335 | 000 |
| 00817740020409 | K120335 | 000 |
| 00817740020393 | K120335 | 000 |
| 00817740020386 | K120335 | 000 |
| 00817740020379 | K120335 | 000 |
| 00817740020362 | K120335 | 000 |
| 00817740020355 | K120335 | 000 |
| 00817740020348 | K120335 | 000 |
| 00817740020331 | K120335 | 000 |
| 00817740020324 | K120335 | 000 |
| 10817740020314 | K120335 | 000 |
| 10817740020307 | K120335 | 000 |
| 10817740020079 | K120335 | 000 |