510(k) clearances

Arthrex DynaNite Staples

Arthrex, Inc. · Orthopedic

K262451Substantially EquivalentTraditionalJDR
Open FDA's page for this record
Third party flag
N
City
Naples
Advisory committee description
Orthopedic
Address 1
1370 Creekside Blvd.
Statement or summary
Summary
Product code
JDR
Zip code
34108
Applicant
Arthrex, Inc.
Decision date
2026-09-01
Decision code
SESE
Country code
US
Device name
Arthrex DynaNite Staples
Advisory committee
OR
Contact
Konrad Wolfmeyer
K number
K262451
State
FL
Date received
2026-07-17
Review advisory committee
OR
Postal code
34108
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Staple, Fixation, Bone
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
3011301313, 1221934, 3013176080, 1417592, 3008951116, 3015718210, 3017210488, 1526711, 3006460162, 3026586698, 2029275, 3010041511, 3010462278, 3019269298, 3011874600, 1835831, 1647149, 3010123256, 1030489, 1226183, 3016851379, 3004365956, 1833920, 3008110533, 1038671, 3032588003, 1048735, 3026576110, 3003604053, 1319660, 1450662, 2936485, 3023808054, 3012470322, 3034676720, 3017980495, 3015183635, 3010470577, 1833986, 2032098 +206 more
FEI number
3011301313, 1221934, 3013176080, 1417592, 3008951116, 3015718210, 3017210488, 1526711, 3006460162, 3026586698, 3003056094, 1000116116, 3010041511, 3010462278, 3019269298, 3008647423, 3002757549, 3011874600, 3010123256, 3016851379, 3004365956, 3002807113, 1000120613, 3008110533, 1038671, 3001644153, 3032588003, 1048735, 3026576110, 3003604053, 1450662, 2936485, 3023808054, 3012470322, 3034676720, 3017980495, 3015183635, 3010470577, 3009110133, 3005827567 +206 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.