510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Teknimed SAS

L Union Haute-Garonne, FR

TEKNIMED SAS appears in FDA device records in L Union Haute-Garonne, FR. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
15
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Teknimed SAS carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Teknimed, S.A.510(k), recall

510(k) clearance history

FDA records hold 15 510(k) clearances for Teknimed SAS between 2003 and 2024. The busiest year on record is 2004, with 3. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Teknimed SAS, by decision year
YearClearances
20032
20043
20061
20071
20081
20092
20112
20171
20231
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242216GENTAFIX® (1, 3, 3MV)MBBSubstantially Equivalent
K230394EUROSCREW NG; EUROSCREW TCP NGMAISubstantially Equivalent
K161114HIGH V+NDNSubstantially Equivalent
K103816COHESION BONE CEMENTNDNSubstantially Equivalent
K103433F20NDNSubstantially Equivalent
K090435VERTECEMNDNSubstantially Equivalent
K083005NANGELLYCSubstantially Equivalent
K080873OPACITY + BONE CEMENTNDNSubstantially Equivalent
K062102ODONCERLYCSubstantially Equivalent
K043593SPINE-FIX BIOMIMETIC BONE CEMENTNDNSubstantially Equivalent
K042911CEMENTEK LVMQVSubstantially Equivalent
K041493CEMENTEKMQVSubstantially Equivalent
K040669CERAFORM BONE VOID FILLERMQVSubstantially Equivalent
K031826TRIHA +MQVSubstantially Equivalent
K032685CEMSTOP CEMENT RESTRICTORLZNSubstantially Equivalent

Registered establishments

FDA registered establishments for Teknimed SAS, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96157883003854593TEKNIMED SAS11_12 rue d Apollo, L Union Haute-Garonne 31240 FR2026and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1099-2023HIGH V+ Spinal Cement System REF T040321KIncorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.Class IIOpen, Classified
Z-0423-2007OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30ccThe firm has determined an incorrect Instructions for Use (IFU) was packaged within the product box.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain