Devices

Exactech Acapella One Interbody Fusion Device Parallel

Model / Serial
Catalog # 05-090-02-1610 // Expiration 07/2023 Serial #'s: 4053365, 4053366, 4053367, 4053368, 4053369, 4053370, 4053371, 4053372, 4053373, 4053374, 4053375, 4053376, 4053377, 4053378, 4053379, 4053380, 4053381, 4053382, and 4053383
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
US distribution in the state of FL and PA.
Product Description
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.
Manufacturer
Exactech, Inc.
1 Event
- Recall of Exactech Acapella One Interbody Fusion Device Parallel

Manufacturer

Exactech, Inc.

Manufacturer Address
Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
Manufacturer Parent Company (2017)
Exactech Inc
Source
USFDA

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