# K973586: Spinal Concepts, Inc., Universal Bone Plate System II

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Nov 7, 1997 after 46 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Universal Bone Plate (UBP) System: named in the summary without a submission number

## Most influential descendants
- K020611: Universal Bone Plate Iii System (Ubp Iii) (2002), 0 descendants of its own

## Indications for use
The Universal Bone Plate (UBP) System II is intended to bring together bone fragments in order to augment fracture healing of the small bones of the foot, wrist and hand.

Source page: https://510kreport.com/device/K973586
Methodology: https://510kreport.com/methodology