The following data is part of a premarket notification filed by B-one Ortho Corp. with the FDA for Juveno Hip System Femoral Stem, B-one Primary Acetabular System Cups.
| Device ID | K182705 |
| 510k Number | K182705 |
| Device Name: | Juveno Hip System Femoral Stem, B-ONE Primary Acetabular System Cups |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | b-ONE Ortho Corp. 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927 |
| Contact | Allison Gecik |
| Correspondent | Allison Gecik b-ONE Ortho Corp. 3 Wing Drive Suite #259 Cedar Knolls, NJ 07927 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-02-14 |
| Summary: | summary |