The following data is part of a premarket notification filed by Toby Orthopaedics with the FDA for Wolf Long Bone Plate System.
| Device ID | K131834 |
| 510k Number | K131834 |
| Device Name: | WOLF LONG BONE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | TOBY ORTHOPAEDICS 401 SW 42nd Ave Suite 200 Miami, FL 33134 |
| Contact | Eric Neyhard |
| Correspondent | Eric Neyhard TOBY ORTHOPAEDICS 401 SW 42nd Ave Suite 200 Miami, FL 33134 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-20 |
| Decision Date | 2013-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816101012084 | K131834 | 000 |
| 00816101011940 | K131834 | 000 |
| 00816101011957 | K131834 | 000 |
| 00816101011964 | K131834 | 000 |
| 00816101011971 | K131834 | 000 |
| 00816101011988 | K131834 | 000 |
| 00816101011995 | K131834 | 000 |
| 00816101012008 | K131834 | 000 |
| 00816101012015 | K131834 | 000 |
| 00816101012022 | K131834 | 000 |
| 00816101012039 | K131834 | 000 |
| 00816101012046 | K131834 | 000 |
| 00816101012053 | K131834 | 000 |
| 00816101012060 | K131834 | 000 |
| 00816101012077 | K131834 | 000 |
| 00816101011933 | K131834 | 000 |