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Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

FDA product code LPH · 527 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3358
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
1984-01-27 – 2026-09-23
LPH 2026-07-10

Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component

Applicant Howmedica Osteonics Corp., Dba Stryker Orthopaedics

K number K261624

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