SBI RADIO-CAPITELLAR IMPLANT— 510(k) K060038

Clearance details

Applicant

Small Bone Innovations, Inc.

Product code

Code JDB

Device class

Class 2

Regulation

21 CFR 888.3160

Advisory panel

Orthopedic

Date received

2006-01-06

Decision date

2006-03-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

New York, NY, US

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Injury

352

Total

352

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2693-2018 — Radio Capitellum Large, Left Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2694-2018 — Radio Capitellum Small, Left. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2695-2018 — Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2696-2018 — Radio Capitellum Small, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2697-2018 — Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2698-2018 — Radial Head Assy Size #3, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2699-2018 — Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2700-2018 — Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2701-2018 — Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2702-2018 — Radio Capitellum, Recon Head, Size #4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024
• Z-2710-2018 — Radio Capitellum Broach Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.Class II·Terminated·Howmedica Osteonics Corp.·20171024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060038.