SIGNATURE PLANNER; SIGNATURE GUIDES
FDA 510(k) clearance K102795 · decided 2011-02-02
Clearance details
- K-number
- K102795
- Device name
- SIGNATURE PLANNER; SIGNATURE GUIDES
- Applicant
- Materialise NV
- Decision
- Substantially Equivalent
- Date received
- 2010-09-27
- Decision date
- 2011-02-02
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- JWH
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Leuven, BE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide d recall (Z-0162-2016) | Materialise N.V. | 2015-10-23 |
| Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Gu recall (Z-1287-2015) | Materialise N.V. | 2015-03-17 |
| REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA- recall (Z-1145-2012) | Biomet, Inc. | 2012-03-02 |