510(k) clearances

TRIVANCE™ Hip Stem

Globus Medical, Inc. · Orthopedic

K254043Substantially EquivalentTraditionalLPH
Open FDA's page for this record
Third party flag
N
City
Audubon
Advisory committee description
Orthopedic
Address 1
2560 General Armistead Ave.
Statement or summary
Summary
Product code
LPH
Zip code
19403
Applicant
Globus Medical, Inc.
Decision date
2026-08-04
Decision code
SESE
Country code
US
Device name
TRIVANCE™ Hip Stem
Advisory committee
OR
Contact
Amber Thomas
K number
K254043
State
PA
Date received
2025-12-17
Review advisory committee
OR
Postal code
19403
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Medical specialty description
Orthopedic
Regulation number
888.3358
Device class
2
Registration number
3007189546, 9616671, 2249615, 3012392319, 1835251, 3014273644, 3000264985, 3013176080, 3017410889, 3007311878, 1526711, 3020282716, 1000547811, 3010097171, 3020155054, 1834331, 3010220595, 3010047454, 3014252644, 3026771806, 3002806470, 3005751028, 3009475821, 3007539489, 3010057495, 3005323511, 3017397663, 3005061536, 3010386387, 3015516266, 3004635447, 3010123256, 3004748528, 3008668801, 3009241418, 9616680, 1833920, 1643817, 3008110533, 1038671 +230 more
FEI number
3007189546, 1000118610, 3002806315, 3012392319, 3014273644, 3013176080, 3000264985, 3007311878, 1526711, 3020282716, 1000547811, 3003714383, 3010097171, 3020155054, 3010220595, 3010047454, 3014252644, 3002807172, 3026771806, 3002806470, 3005751028, 3009475821, 3007539489, 3010057495, 3005323511, 3017397663, 3005061536, 3010386387, 3015516266, 3004635447, 3010123256, 3004748528, 1000132037, 3008668801, 3009241418, 3002459190, 1643817, 3002807113, 3008110533, 1038671 +230 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.