INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS— 510(k) K993259
Substantially EquivalentSulzer Orthopedics, Inc.
FDA 510(k) clearance K993259 for INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS, Substantially Equivalent on 2000-03-10. Applicant: Sulzer Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sulzer Orthopedics, 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
- Traditional
- Location
- Austin, TX, US
Recent devices under product code LPH
view allMore clearances from Sulzer Orthopedics, Inc.
view allAdverse 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 K993259
K-number listed on FDA's recall record- Z-1294-2023 — CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
- Z-1132-2015 — CoCr Femoral Head - A modular head component is used in conjunction with a femoral stem component for replacement of the proximal femur in total hip arthroplasty.
- Z-0222-2013 — CoCr Head, sterile, Rx
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K993259.
Data sourced from openFDA. This site is unofficial and independent of the FDA.