REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
FDA 510(k) clearance K002747 · decided 2000-12-15
Clearance details
- K-number
- K002747
- Device name
- REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-05
- Decision date
- 2000-12-15
- Days to decision
- 101 days
- Clearance type
- Abbreviated
- Product code
- LPH
- Device class
- 2
- Regulation number
- 888.3358
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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