EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM— 510(k) K132582

Clearance details

Applicant

Exactech, Inc.

Product code

Code OVE

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2013-08-16

Decision date

2014-02-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainesville, FL, US

• K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
• K261451 — ZSAlign Cervical Interbody System2026-07-31
• K262094 — E3D-C Interbody System2026-07-22
• K261279 — DeltaNEC Interbody System2026-06-22
• K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

• K260583 — Equinoxe® Shoulder System2026-04-14
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K243448 — Equinoxe® Shoulder System2025-08-01
• K243275 — Equinoxe® Scapula Fracture System2025-06-26
• K243839 — Alteon® HA Femoral Stems2025-03-10

Injury

293

Malfunction

710

Total

1,003

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-0809-2016 — Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Is to be used with autogenous bone graft and supplemental internal fixation and is implanted via an open anterior approach.Class II·Terminated·Exactech, Inc.·20150928

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132582.