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

ELSTREE Hertfordshire, GB

APATECH LTD. appears in FDA device records in ELSTREE Hertfordshire, GB. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
8
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 8 510(k) clearances for Apatech Ltd. between 2004 and 2009. The busiest year on record is 2008, with 4. The most recent is 2009, with 1.

Clearances by year, as a table
510(k) clearance decisions for Apatech Ltd., by decision year
YearClearances
20042
20071
20084
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K090850ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTELYCSubstantially Equivalent
K082575ACTIFUSE BONE GRAFT SUBSTITUTE AND ABX E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTESMQVSubstantially Equivalent
K081979ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K082073ACTIFUSE FLOW BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K080736ACTIFUSE SHAPE BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K071206ACTIFUSE ABX E-Z-FIL PUTTY BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K040082PORE-SI BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent
K033722APAPORE BONE GRAFT SUBSTITUTEMQVSubstantially Equivalent

Registered establishments

FDA registered establishments for Apatech Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30044509733004450973APATECH LTD.360 CENTENNIAL AVENUE, ELSTREE Hertfordshire WD6 3TJ GB2026

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-1922-2016Actifuse ABX/Actifuse MIS System A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.Class IITerminated

Verification record

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