APEX KNEE MODULAR TIBIA SYSTEM— 510(k) K101994
Substantially EquivalentOmnlife Science
FDA 510(k) clearance K101994 for APEX KNEE MODULAR TIBIA SYSTEM, Substantially Equivalent on 2010-09-28. Applicant: Omnlife Science. Device class: 2.
Clearance details
- Applicant
- Omnlife Science
- 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
- Traditional
- Location
- East Taunton, MA, US
Recent devices under product code JWH
view allMore clearances from Omnlife Science
view all- K142201 — OMNI Interface Acetabular System
- K112779 — APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
- K101575 — APEX MODULAR HEAD, SIZE 28 ,32, 26 AND 40 MM+10.5 OFFSET, MODELS 302810, 303210,303610,304010
- K100151 — APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM)
- K073602 — MODIFICATION TO: APEX KNEE SYSTEM
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 K101994
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 K101994.
Data sourced from openFDA. This site is unofficial and independent of the FDA.