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

Berlin, DE

MERETE GMBH appears in FDA device records in Berlin, DE. FDA records list 27 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
27
PMA records
0
Recall records
5
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Merete GmbH 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.

  • Merete Medical, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 27 510(k) clearances for Merete GmbH between 2005 and 2018. The busiest year on record is 2010, with 4. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Merete GmbH, by decision year
YearClearances
20053
20061
20071
20082
20092
20104
20111
20122
20133
20142
20152
20162
20171
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K181026OsteoBridge™ IDSF SystemHSBSubstantially Equivalent
K172213MECRON Cannulated Screw SystemHWCSubstantially Equivalent
K160548MC-Subtalar(TM) IIHWCSubstantially Equivalent
K152187MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off ScrewsHWCSubstantially Equivalent
K151762PediatrOS RigidTack/FlexTackJDRSubstantially Equivalent
K142451OsteoBridge IDSF - Intramedullary Diaphyseal Segmental Defect Fixation Rod SystemHSBSubstantially Equivalent
K141377BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARDLZOSubstantially Equivalent
K140069LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0HRSSubstantially Equivalent
K132226METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHTHRSSubstantially Equivalent
K123619INTRABLOCK BIOBALL HIP SYSTEM (IBS)LZOSubstantially Equivalent
K130400MERETEC CS, CORTICAL SCREWSHWCSubstantially Equivalent
K120787MERETE LOCKING BONE PLATE SYSTEM IIIHRSSubstantially Equivalent
K120978OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLARHSBSubstantially Equivalent
K113303OSLEOBRIDGE IDSF SPACER CONECTORHSBSubstantially Equivalent
K102777TWISTCUT ENDOSORB SCREWSJDWSubstantially Equivalent
K102688MERETE LOCKING BONE PLATE SYSTEM IIKTTSubstantially Equivalent
K101939OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEMHSBSubstantially Equivalent
K100414PROTOE ENDOSORB SMALL HAMMER TOE PINJDWSubstantially Equivalent
K091798MERETE COMPRESSION SCREWSHWCSubstantially Equivalent
K090063MERETE LOCKING BONE PLATE SYSTEMKTTSubstantially Equivalent
K081513MERETE 3.0 AND 3.5 MM LOCKING SCREWSHWCSubstantially Equivalent
K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMLZJSubstantially Equivalent
K063487MERETE BLP SMALL FRAGMENT LOCKING BONE PLATEKTTSubstantially Equivalent
K051965OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEMHSBSubstantially Equivalent
K051323MERETE TWISTCUT SNAP-OFF BONE SCREWHWCSubstantially Equivalent
K050924MERETE DUOTHREADTM BONE SCREWHWCSubstantially Equivalent
K050457MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEMKTTSubstantially Equivalent

Registered establishments

FDA registered establishments for Merete GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30029496143002949614MERETE GMBH102 ALT LANKWITZ, BERLIN D-12247 DE2026and 18 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-0650-2022Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx OnlyIncorrect marketing label (25 mm) was applied to product size 20 mm.Class IITerminated
Z-0438-2021OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus)Product may be mislabeled.Class IITerminated
Z-0437-2021OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)Product may be mislabeled.Class IITerminated
Z-0436-2021OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)Product may be mislabeled.Class IITerminated
Z-0435-2021OsteoBridge Intremedullary Knee Arthrodesis (IKA) nailsProduct may be mislabeled.Class IITerminated

Verification record

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