# P850035: SpF® Implantable Spinal Fusion Stimulator

- Pathway: PMA
- Applicant: Ahp Eos Buyer, Inc.
- Decided: Apr 30, 1987 after 699 days
- Product code: LOE (Stimulator, Invasive Bone Growth)
- Device class: 3
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 19, 2018 · Class I · Z-0287-2019: Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
- Apr 20, 2017 · Class I · Z-2118-2017: Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during
- Apr 20, 2017 · Class I · Z-2119-2017: Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during

Source page: https://510kreport.com/device/P850035
Methodology: https://510kreport.com/methodology