ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923— 510(k) K031572
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K031572 for ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923, Substantially Equivalent on 2003-06-24. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code LPH
view allMore clearances from Zimmer, Inc.
view all- K260831 — Z1 Hip System
- K261683 — Augment Off-Axis Instrument System
- K251840 — Zimmer® Persona® Personalized Knee System
- K260182 — Avenir® Müller Stem; Avenir Complete Hip System
- K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)
Adverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K031572
K-number listed on FDA's recall record- Z-2582-2017 — Xl por st 24.0x220mm, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
- Z-2583-2017 — Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031572.
Data sourced from openFDA. This site is unofficial and independent of the FDA.