ClearanceBrief
Company ยท US

Linkbio Corp.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2025. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
50recalls (1 in 12 months)
50recalls that name a 510(k)

Product codes

CodeDeviceRecords
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer32
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer17
QHEShoulder Arthroplasty Implantation System2
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 20, 2025K241470CORE Shoulder System
LinkBio Corp.
QHE
Oct 25, 2019K190181Instruments for LINK MEGASYSTEM-C Family
LinkBio Corp.
KRO

Latest recalls

DateFirm and productCodeLinked 510(k)
Apr 10, 2026Linkbio Corp.
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Open, Classified		 QHEK241470
Jun 1, 2023Linkbio Corp.
LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Open, Classified		 JWHK202924
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
Open, Classified		 KROK152431
K212742
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46
Open, Classified		 HSXK954186
May 4, 2023Linkbio Corp.
LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
Open, Classified		 HSXK954186
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