510(k) clearances

WasherCap™ Fixation System

Abanza Tecnomed S.L · Orthopedic

K250238Substantially EquivalentSpecialMBI
Open FDA's page for this record
Third party flag
N
City
Mutilva
Advisory committee description
Orthopedic
Address 1
Calle Nueva 29
Statement or summary
Summary
Product code
MBI
Zip code
31192
Applicant
Abanza Tecnomed S.L
Decision date
2025-02-25
Decision code
SESE
Country code
ES
Device name
WasherCap™ Fixation System
Advisory committee
OR
Contact
Ander Menaut
K number
K250238
Date received
2025-01-27
Review advisory committee
OR
Postal code
31192
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Fastener, Fixation, Nondegradable, Soft Tissue
Medical specialty description
Orthopedic
Regulation number
888.3040
Device class
2
Registration number
3033273526, 3005064037, 3012818475, 3018094310, 3008868758, 3011580264, 3002579136, 8043792, 3014302784, 3021008900, 3032412536, 3007319107, 3017034897, 1835572, 3016926753, 3008837339, 3008262872, 3008749819, 1000484830, 3010047402, 3005381997, 3019807891, 3030514683, 2244478, 3025141, 3007993775, 3005180920, 3032314868, 3013302242, 3006946276, 3010060157, 3013767421, 3016727307, 3006742481, 2530154, 3009826895, 3006108336, 3006981798, 2090040, 3021632375 +237 more
FEI number
3033273526, 3005064037, 3012818475, 3018094310, 1000345108, 3008868758, 3011580264, 3002579136, 3014302784, 3021008900, 3032412536, 3007319107, 3017034897, 3016926753, 3001237338, 3008837339, 3008262872, 3008749819, 1000484830, 3010047402, 3005381997, 3019807891, 3030514683, 3005180920, 3007993775, 1000069183, 3002808269, 3032314868, 3013302242, 3006946276, 3010060157, 3013767421, 3016727307, 3006742481, 3002615969, 3009826895, 1000306303, 3006108336, 3006981798, 3021632375 +237 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.