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510(k) K101356

Device
SPACER-K, SPACER-G, SPACER-S
Applicant
TECRES SPA
510(k) number
K101356
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
2011-09-20
Date received
2010-05-14
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHRISTINE BRAUER
Address
7 Trl. House Ct. Rockville MD US 20850 20850

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JWH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262057GMK ExtensionMedacta International SA2026-09-15
K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts2026-09-11
K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.2026-09-10
K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.2026-09-08
K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.2026-09-04
K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.2026-09-01
K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.2026-08-07
K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.2026-07-31
K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.2026-07-23
K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC2026-06-25
K261032NovoKnee (SteriKnee)NovoSource2026-04-27
K253793Materialise TKA Guide SystemMaterialise NV2026-01-06
K252974EMPOWR KneeEncore Medical L.P.2025-12-19
K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC2025-11-19
K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.2025-10-29

Legacy Summary#

summary

FDA Review#

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