510(k) clearances

CORE Shoulder System

LinkBio Corp. · Orthopedic

K241470Substantially EquivalentTraditionalQHE
Open FDA's page for this record
Third party flag
N
City
Dover
Advisory committee description
Orthopedic
Address 1
69 King St.
Statement or summary
Summary
Product code
QHE
Zip code
07801
Applicant
LinkBio Corp.
Decision date
2025-02-20
Decision code
SESE
Country code
US
Device name
CORE Shoulder System
Advisory committee
OR
Contact
Deniz Kortan
K number
K241470
State
NJ
Date received
2024-05-24
Review advisory committee
OR
Postal code
07801
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Shoulder Arthroplasty Implantation System
Medical specialty description
Orthopedic
Regulation number
888.3660
Device class
2
Registration number
3009555447, 3007841013, 3006990600, 1822565, 1649390, 9617840, 3002579136, 3011724582, 3003018722, 3014833750, 2249608, 3014027736, 3000931034, 3009555440, 3010236732, 3005180920, 3008110533, 1043534, 1220246, 3016851379, 3008388276, 3013552417, 3013561205, 3005718816, 3014262693, 3015806723, 3010331645, 3015231789, 1064858, 3003998208, 3031914485, 3004983210, 3020704423, 3012470322, 3006721341, 3014004349
FEI number
3009555447, 3007841013, 3006990600, 3002579136, 3011724582, 3003018722, 3014833750, 3000931034, 3014027736, 3009555440, 3010236732, 3005180920, 3008110533, 1043534, 1220246, 3016851379, 3008388276, 3013552417, 3013561205, 3005718816, 3014262693, 3015806723, 3010331645, 3015231789, 3008397795, 3003998208, 3031914485, 1000220733, 3004983210, 3020704423, 3012470322, 3006721341, 3000718467, 3014004349, 3003714383, 3002943267
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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.