510(k) clearances

GFS - Sterile Screws and Top Hat

T.A.G. Medical Products Corporation, Ltd. · Orthopedic

K253858Substantially EquivalentSpecialHWC
Open FDA's page for this record
Third party flag
N
City
Gaaton Northern
Advisory committee description
Orthopedic
Address 1
Kibbutz Gaaton
Statement or summary
Summary
Product code
HWC
Zip code
2513000
Applicant
T.A.G. Medical Products Corporation, Ltd.
Decision date
2026-08-05
Decision code
SESE
Country code
IL
Device name
GFS - Sterile Screws and Top Hat
Advisory committee
OR
Contact
Shlomi Dines
K number
K253858
Date received
2025-12-03
Review advisory committee
OR
Postal code
2513000
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Screw, Fixation, Bone
Medical specialty description
Orthopedic
Regulation number
888.3040
Device class
2
Registration number
2249615, 1221934, 3013176080, 3003678543, 3008951116, 3015718210, 3007922509, 2431166, 9610921, 3006849754, 3013843055, 2029275, 9611274, 3010057495, 3012447612, 2648623, 1835831, 3004635447, 3010123256, 3009149199, 3042765769, 3009532798, 3023808054, 3031261833, 2437731, 2032098, 3009998573, 3043026734, 3007583504, 1221051, 1424434, 3004049923, 3013540005, 9611827, 3043543260, 3034525, 3009153862, 3015167917, 3004549189, 2024024 +623 more
FEI number
1221934, 3013176080, 3003678543, 3008951116, 3015718210, 3007922509, 3003056094, 3006849754, 3013843055, 1000116116, 3010057495, 3012447612, 2648623, 3004635447, 3010123256, 3009149199, 3042765769, 3002459190, 3002807113, 3009532798, 3023808054, 3031261833, 3002929183, 3009998573, 3043026734, 3007583504, 1221051, 3003110073, 3004049923, 1000115656, 3013540005, 3002786339, 3043543260, 3009153862, 3015167917, 3000215273, 2024024, 3010673850, 3009540749, 3011656326 +623 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.