# K822780: Cervical Brace

- Pathway: 510(k) (Traditional)
- Applicant: Jerome Medical
- Decided: Oct 6, 1982 after 22 days
- Product code: JEC (Component, Traction, Invasive)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040363: Ceramic Tipped Skull Pin (2004), 1 descendant of its own
- K023959: Jerome Glass Ring (2003), 1 descendant of its own
- K090733: PMT Halo System (2009), 0 descendants of its own
- K051918: Resolve Open Back Halo Rings (2005), 0 descendants of its own

## Recalls of this device
- Jun 21, 2018 · Class II · Z-0997-2019: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly

Source page: https://510kreport.com/device/K822780
Methodology: https://510kreport.com/methodology