S-ROM ZTP UHMWPE ACETABULAR CUP— 510(k) K951726
Substantially EquivalentJoint Medical Products Corp.
FDA 510(k) clearance K951726 for S-ROM ZTP UHMWPE ACETABULAR CUP, Substantially Equivalent on 1995-06-21. Applicant: Joint Medical Products Corp.. Device class: 2.
Clearance details
- Applicant
- Joint Medical Products Corp.
- Product code
- Code JDI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3350
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stamford, CT, US
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More clearances from Joint Medical Products Corp.
view all- K955511 — ARTHOPOR I & II ACETABULAR CUP/ARTHOPOR II OBLONG ACETABULAR CUP
- K954935 — S-ROM FEMORAL HIP STEM - SIZE 14 X 8
- K944321 — S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II
- K951084 — S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
- K951000 — ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP SYSTEM
Adverse events under product code JDI
product code JDI- Death
- 65
- Injury
- 12,943
- Malfunction
- 1,681
- Total
- 14,689
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.