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510(k) K182705

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups by B-One Ortho, Corp. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2019
Date Received
September 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by B-One Ortho, Corp.

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  • K202429 — Mobio Total Knee System (October 23, 2020)
  • K183025 — MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO (January 28, 2019)
  • K180446 — b-ONE Total Knee System (October 12, 2018)
  • K173380 — b-ONE® Total Hip System (August 30, 2018)

Other clearances for product code LZO

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  • K251906 — Z1 Hip System (July 18, 2025)
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  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243043 — Origin™ Cemented Hip Stem (May 2, 2025)
  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)