510(k) clearances

Cerclage Wires;K-wires;Steinmann Pins

MK Medical GmbH · Orthopedic

K262126Substantially EquivalentTraditionalHTY
Open FDA's page for this record
Third party flag
N
City
Emmingen-Liptingen
Advisory committee description
Orthopedic
Address 1
Jahnstraße 14
Statement or summary
Summary
Product code
HTY
Zip code
78576
Applicant
MK Medical GmbH
Decision date
2026-10-22
Decision code
SESE
Country code
DE
Device name
Cerclage Wires;K-wires;Steinmann Pins
Advisory committee
OR
Contact
Jakob Denzel
K number
K262126
Date received
2026-06-24
Review advisory committee
OR
Postal code
78576
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Pin, Fixation, Smooth
Medical specialty description
Orthopedic
Regulation number
888.3040
Device class
2
Registration number
3025266, 3009746186, 9617297, 3012818475, 3008868758, 1822565, 3011580264, 3002579136, 8043792, 3013011598, 3014302784, 3014833750, 3021008900, 3011656326, 1720747, 1835572, 1226544, 3007366790, 3008749819, 3022472578, 3006801265, 3025141, 3005180920, 3009381600, 2244478, 3015212339, 3007993775, 3007125392, 3013302242, 3016727307, 3006742481, 2530154, 3009826895, 3014527928, 3010155648, 3008114965, 3003477135, 3015151147, 3015806723, 3005641619 +245 more
FEI number
3009746186, 3012818475, 3008868758, 3011580264, 3002579136, 3014833750, 3013011598, 3014302784, 3021008900, 3003756816, 3011656326, 3002807036, 1720747, 3001406084, 3008749819, 3022472578, 3006801265, 3005180920, 3009381600, 3007125392, 3015212339, 3007993775, 1000139987, 3002808269, 3013302242, 2523865, 3016727307, 3006742481, 3009826895, 3003414678, 3007282753, 3014527928, 3002807231, 3003015552, 3010155648, 3008114965, 3003477135, 3015151147, 3015806723, 3005641619 +245 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.