Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614841

FEI Number

3002808402

Entity Name

TECRES SPA

City/State/Country

VERONA Veneto, IT

Establishment Address

VIA ANDREA DORIA 6, SOMMACAMPAGNA, VERONA Veneto 37066, IT

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

TECRES SPA (Owner Number: 9033624)

Owner / Operator Contact Address

VIA ANDREA DORIA 6, --, SOMMACAMPAGNA VERONA, IT-NOTA 37066, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092773

PMA Number

N/A

All Registered Proprietary Names

Rally HV AB Bone Cement 40 Grams Rally MV AB Bone Cement 40 Grams Rally HV AB All In One System 70 Grams Rally MV AB All In One System 70 Grams Mendec Kypho Set Monolateral Kyphoplasty Balloon Catheter Mendec Kypho Set Bilateral Bowl and Spatula Cemex System Container Shakit Cemex System Mixer MectaCem Bowl 2Mix Mendec Kypho Set Bilateral Kyphoplasty Tool Kit Mendec Kypho Set Monolateral InterSpace Shoulder InterSpace Tapered Wedge Stem InterSpace Hip InterSpace Knee Interspace Tapered Wedge Stem XL InterSpace Hip XL MectaCem-X HV Conflow Bone Cement Cemex Isoplastic 1/2 pack MectaCem-X LV Cemex Isoplastic Cemex RX Mendec Aqua Mendec Aqua Cartridge Kyphoplasty Tool Kit Mendec Kypho Set Bilateral Mendec Kypho Set Monolateral Mendec Spine HV System CEMENT KIT Mendec Spine HV TEKTONA HV US Bone Cement Mendec Spine Kyverment SPSCM4U U00249 SPSCM4U U00275 SPSCM4U U00291 SPSCM4U U00299 SPSCM4U U00234 SPSCM4U U00220 SPSCM4U U00240 SPSCM4U U00255 SPSCM4U U00300 InterSpace GV Hip XL Tapered Wedge Stem Interspace GV Hip Spacer InterSpace GV Hip Tapered Wedge Stem Mendec V Fill Kyphon VuE Bone Cement Rally All In One Cement Gun Xtruder GUN-01 Bone Injection Needles Mendec Kypho Set Bilateral Mendec Kypho Set Monolateral 2Mix Gun Kyphoplasty Tool Kit Temporary Elbow Spacer with Gentamicin & Vancomycin - custom Mendec Kypho Set Monolateral Mendec Kypho Set Bilateral Kyphoplasty Tool Kit HP Connection Tube Cannula for Knee Shoulder Cannula Hip Cannula Freezer Ring Mendec Spine Kit Rally HV Bone Cement 40 Grams Rally MV Bone Cement 40 Grams RALLY MV ALL IN ONE SYSTEM 70 GRAMS RALLY HV ALL IN ONE SYSTEM 70 GRAMS Cemex Genta Cemex Genta System Cemex System Genta Fast Conflow G Bone Cement MectaCem-X LV with Gentamicin MectaCem-X HV with Gentamicin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2015-09-11
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-09-11
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-11-24
HXG	Tamp	Orthopedic	Class 1	888.4540	2025-11-24
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2014-02-03
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2014-02-03
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2014-02-03
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2014-02-03
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	Class 1	888.4210	2001-06-14
OCJ	Spinal Channeling Instrument, Vertebroplasty	Orthopedic	Class 1	888.4540	2025-12-15
HSD	Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	Orthopedic	Class 2	888.3690	2011-12-22
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2011-12-22
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2010-11-23
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2011-12-01
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2011-12-01
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2011-12-01
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2011-12-01
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2012-06-04
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-10-31
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2007-12-21
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2020-05-28
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2020-05-28
OAR	Injector, Vertebroplasty (Does Not Contain Cement)	Orthopedic	Class 1	888.4200	2008-10-30
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2013-07-05
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2013-07-05
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2005-12-07
KWS	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Orthopedic	Class 2	888.3660	2018-02-12
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2018-10-30
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2018-10-30
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2018-10-30
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2012-06-04
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2012-12-03
KWL	Prosthesis, Hip, Hemi-, Femoral, Metal	Orthopedic	Class 2	888.3360	2026-01-15
KWY	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Orthopedic	Class 2	888.3390	2026-01-15
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2026-01-15
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2015-06-05
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2022-04-27
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2003-08-11
JDC	Prosthesis, Elbow, Constrained, Cemented	Orthopedic	Class 2	888.3150	2013-02-01
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2001-06-12
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2001-06-14
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2007-12-21
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2015-09-11
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2023-06-07
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2009-12-04
MBB	Bone Cement, Antibiotic	Orthopedic	Class 2	888.3027	2009-12-04

Official Correspondent

MICHELE PERRINO

US Agent Details

CHRISTINE BRAUER Email: chris.brauer@comcast.net Phone: (301) 5451990

Related Public Records

Same Entity

TECRES SPA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K901338	Kirschner Medical Corp.	KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM	1990-05-22
K030577	Stelkast Company	PROVEN MODULAR TIBIAL TRAY	2003-03-25
K153310	Total Joint Orthopedics, Inc.	Klassic Knee System	2015-12-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0001-2019	Smith & Nephew, Inc.	2	Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229
Z-0002-2019	Smith & Nephew, Inc.	2	JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149
Z-0003-2017	Zimmer Biomet, Inc.	2	Vanguard 360 Revision Knee System Knee prostheses
Z-0003-2019	Smith & Nephew, Inc.	2	JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614841. Last updated year: 2026. Please use registration number 9614841 when referencing this establishment in official correspondence.