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Medtronic Sofamor Danek USA, Inc.

Country / Region:United States (US)

510(k) submissions

2

Latest clearance

2026-06-05

Product codes

2
GEI, OLO

Cited as predicate

1

Product areas

FDA product code distribution

510(k) submissions

2 total

Showing 12

K numberDevice nameDecision
K253656OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System2026-06-05
K231184CD Horizon™ Spinal System2023-05-26

Company profile

Canonical name
Medtronic Sofamor Danek USA, Inc.
Country / Region
United States(US)
Address
1800 Pyramid Pl. Memphis,  TN  38132

Predicate manufacturers

Companies whose devices this company cited as predicates

0

No predicate manufacturers found

This company has not cited predicate devices with known manufacturers yet

Citing manufacturers

Companies that cited this company's devices as predicates

1

1 manufacturers