EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE— 510(k) K051385
Substantially EquivalentBiomet, Inc.
FDA 510(k) clearance K051385 for EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE, Substantially Equivalent on 2005-08-05. Applicant: Biomet, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomet, Inc.
- Product code
- Code KWI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3170
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code KWI
view allMore clearances from Biomet, Inc.
view allAdverse events under product code KWI
product code KWI- Injury
- 490
- Total
- 490
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 K051385
K-number listed on FDA's recall record- Z-0269-2018 — ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.
- Z-1615-2014 — ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051385.
Data sourced from openFDA. This site is unofficial and independent of the FDA.