TEKNIMED SAS

FDA Device Registration & Listing · L Union Haute-Garonne, FR · Registration 9615788

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615788
FEI Number
3003854593
Entity Name
TEKNIMED SAS
City/State/Country
L Union Haute-Garonne, FR
Establishment Address
11_12 rue d Apollo, L Union Haute-Garonne 31240, FR
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Teknimed (Owner Number: 9040657)
Owner / Operator Contact Address
8 rue du Corps Franc-Pommies, Vic en Bigorre, FR-65 65500, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

GENTAFIX (1 3 3MV) Dynamo Spinal cement System Gun MV Max V Cement Mixing System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2011-12-05
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2003-07-17
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2008-09-17
MQV Filler, Bone Void, Calcium Compound Orthopedic Class 2 888.3045 2008-09-17
HWX Tap, Bone Orthopedic Class 1 888.4540 2024-01-16
MJG Device, Percutaneous, Biopsy General, Plastic Surgery Class 1 878.4800 2023-08-07
MBB Bone Cement, Antibiotic Orthopedic Class 2 888.3027 2025-08-04
LOD Bone Cement Orthopedic Class 2 888.3027 2025-08-04
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2023-12-12
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2007-08-14
HXX Screwdriver Orthopedic Class 1 888.4540 2023-08-23
OAR Injector, Vertebroplasty (Does Not Contain Cement) Orthopedic Class 1 888.4200 2008-09-26
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2007-08-14
LYC Bone Grafting Material, Synthetic Dental Class 2 872.3930 2009-05-04
OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic Class 1 888.4540 2011-07-07
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2008-09-26

Official Correspondent

Stephanie Salles

US Agent Details

Barry Sands Business: Regulatory/Quality Management Information Source, Inc. Email: fdaadminsupport@rqmis.com Phone: (978) 8345701

Related Public Records

Same Entity

Teknimed
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
K180121 Cellumed Co., Ltd. Rafugen DBM 2018-04-11
K062691 Takiron Co., Ltd. COMPORUS 2008-04-15
K023703 Berkeley Advanced Biomaterials, Inc. BI-OSTETIC 2003-01-30
K173933 Xenco Medical, LLC Sorrento Bioglass Bone Graft Substitute 2018-09-13
K203334 Acuitive Technologies, Inc. The Citrefix Knotless Suture Anchor 2021-02-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2011 Medical Device Technologies, Inc. 1
Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows: Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M. Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ. Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1 Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3. Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS Model Number: 763116200X Lot #'s 121KN Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX. Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO. Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I. Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF. Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8. Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW. Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6. Model Number: 763418250X Lot #s 92751X60, 00671ZRL, Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615788. Last updated year: 2026. Please use registration number 9615788 when referencing this establishment in official correspondence.
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