ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER)— 510(k) K971752
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K971752 for ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER), Substantially Equivalent on 1997-07-30. Applicant: Zimmer, Inc.. Device class: 2.
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code LZO
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- K253566 — Affixus Retrograde Femoral Nailing System
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Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.