510(k) clearances

Momentum Acetabular Cup System

United Orthopedic Corporation · Orthopedic

K253948Substantially EquivalentTraditionalLZO
Open FDA's page for this record
Third party flag
N
City
Kaohsiung City
Advisory committee description
Orthopedic
Address 1
# 16. Luke 1st Rd. Luzhu Dist.
Statement or summary
Summary
Product code
LZO
Zip code
82151
Applicant
United Orthopedic Corporation
Decision date
2026-09-02
Decision code
SESE
Country code
TW
Device name
Momentum Acetabular Cup System
Advisory committee
OR
Contact
Lois Ho
K number
K253948
Date received
2025-12-10
Review advisory committee
OR
Postal code
82151
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Medical specialty description
Orthopedic
Regulation number
888.3353
Device class
2
Registration number
3016438761, 9616671, 2249615, 3012392319, 1835251, 3014273644, 3000264985, 3013176080, 3007311878, 3042508254, 1526711, 3020282716, 1000547811, 1835831, 3010097171, 3020155054, 1834331, 3010220595, 3010047454, 3014252644, 3026771806, 3002806470, 3005751028, 3009475821, 3010057495, 3005323511, 3010468876, 3007391088, 3010386387, 3012523063, 3015516266, 3004635447, 3004748528, 3017397663, 3008668801, 3009241418, 3003791208, 9616680, 1833920, 1643817 +238 more
FEI number
1000118610, 3016438761, 3002806315, 3012392319, 3014273644, 3013176080, 3000264985, 3007311878, 3042508254, 1526711, 3020282716, 1000547811, 3003714383, 3010097171, 3020155054, 3010220595, 3010047454, 3014252644, 3002807172, 3026771806, 3002806470, 3005751028, 3009475821, 3010057495, 3005323511, 3017397663, 3007391088, 3010386387, 3012523063, 3015516266, 3004635447, 3004748528, 1000132037, 3008668801, 3009241418, 3003791208, 3002459190, 1643817, 3002807113, 3008110533 +238 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.