Modification to Space Cpsxl Bone Cement

by Dfine, Inc. 510(k)

Active United States

510(k) K072496

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK072496	Date5 Oct 2007Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K072496
FDA Product Code: NDN

Device Class: Class II
Regulation: 21 CFR Part 888.3027
Advisory Committee: Orthopedic
FDA Decision: SESE Substantially Equivalent

Other devices from Dfine, Inc.

Space Cpsxl Bone Cement

Class II
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Class II
Ablation Instrument, Model 1635; Ablation Multiplex Catheter, Model 1682

Class II
Space 360 Delivery System

Class II