IMPLEX A-240 HEP ACETABULAR CUP SYSTEM— 510(k) K964509
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K964509 for IMPLEX A-240 HEP ACETABULAR CUP SYSTEM, Substantially Equivalent on 1997-06-19. Applicant: Implex Corp.. Device class: 2.
Clearance details
- Applicant
- Implex Corp.
- 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
- Rockville, MD, US
Recent devices under product code LPH
view allMore clearances from Implex Corp.
view all- K051978 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT
- K051196 — TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
- K040487 — TRABECULAR METAL KNEE SYSTEM AUGMENTS
- K040630 — TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
- K040756 — THE TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 10-340-XXXXX
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 K964509
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964509.
Data sourced from openFDA. This site is unofficial and independent of the FDA.