510(k) clearances

TeKBrace Knotless Anchor

TheraMicro · Orthopedic

K263352Substantially EquivalentSpecialMBI
Open FDA's page for this record
Third party flag
N
City
Cordova
Advisory committee description
Orthopedic
Address 1
51 Germantown Ct.
Statement or summary
Summary
Product code
MBI
Zip code
38018
Applicant
TheraMicro
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
TeKBrace Knotless Anchor
Advisory committee
OR
Contact
Christine Scifert
K number
K263352
State
TN
Date received
2026-09-23
Review advisory committee
OR
Postal code
38018
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.