The following data is part of a premarket notification filed by Bionix Development Corp. with the FDA for T-form Extremity Immobilizer, Model Rt-6060.
| Device ID | K100264 |
| 510k Number | K100264 |
| Device Name: | T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 |
| Classification | Accelerator, Linear, Medical |
| Applicant | BIONIX DEVELOPMENT CORP. 5154 ENTERPRISE BLVD. Toledo, OH 43612 |
| Contact | James Huttner |
| Correspondent | James Huttner 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 | 2010-01-28 |
| Decision Date | 2010-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817740020485 | K100264 | 000 |