SIGNATURE PLANNER; SIGNATURE GUIDES— 510(k) K102795
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K102795 for SIGNATURE PLANNER; SIGNATURE GUIDES, Substantially Equivalent on 2011-02-02. Applicant: Materialise NV. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- 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
- Leuven, BE
Recent devices under product code JWH
view allMore clearances from Materialise NV
view all- K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
- K251964 — Mimics Thoracic Planner
- K253308 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models
- K253793 — Materialise TKA Guide System
- K251554 — Materialise TKA Guide 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 K102795
K-number listed on FDA's recall record- Z-1941-2016 — Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
- Z-0162-2016 — Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
- Z-1287-2015 — Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102795.
Data sourced from openFDA. This site is unofficial and independent of the FDA.