THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0— 510(k) K012866
Substantially EquivalentImplex Corp.
FDA 510(k) clearance K012866 for THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0, Substantially Equivalent on 2001-09-26. Applicant: Implex Corp.. Device class: 2.
Clearance details
- Applicant
- Implex Corp.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Allendale, NJ, US
Recent devices under product code JWH
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 JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 K012866
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 K012866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.