510(k) clearances

Tontarra Punches and Rongeurs

Tontarra Medizintechnik GmbH · Neurology

K260446Substantially EquivalentTraditionalHAE
Open FDA's page for this record
Third party flag
N
City
Wurmlingen
Advisory committee description
Neurology
Address 1
Daimlerstraße 15
Statement or summary
Summary
Product code
HAE
Zip code
78573
Applicant
Tontarra Medizintechnik GmbH
Decision date
2026-09-15
Decision code
SESE
Country code
DE
Device name
Tontarra Punches and Rongeurs
Advisory committee
NE
Contact
Andreas Birk
K number
K260446
Date received
2026-02-11
Review advisory committee
NE
Postal code
78573
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Rongeur, Manual
Medical specialty description
Neurology
Regulation number
882.4840
Device class
2
Registration number
8010697, 3014334038, 1417592, 3011245468, 2027754, 9680260, 9610612, 3005641619, 8010769, 3005528784, 3016112537, 3006554912, 8010422, 3010041511, 9680515, 9614945, 1424478, 1220477, 9615004, 9611814, 8044057, 3011137372, 1649518, 3014967969, 1057946, 9610905, 8010877, 9615005, 3010687973, 3012995405, 2085947, 8040233, 1058020, 2916714, 3004893332, 1836161, 3016450051, 1421101, 3009704301, 3008864603 +24 more
FEI number
3014334038, 3002806315, 3001130644, 1417592, 3011245468, 2027754, 3002807464, 3005641619, 3005528784, 1000140363, 3016112537, 3002315844, 3006554912, 3008238512, 2648666, 3010041511, 1220477, 3003944071, 3002750084, 1000222207, 3014967969, 3004053982, 3002902165, 3010687973, 3005969827, 3012995405, 3000204191, 2916714, 3004893332, 3016450051, 3005977257, 1421101, 3009704301, 3008864603, 3006509795, 1450662, 1923569, 3005747797, 3003499455, 3004215117 +24 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.