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

Tampere, FI

Bionx Implants, Inc. appears in FDA device records in Tampere, FI. FDA records list 30 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
30
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 30 510(k) clearances for Bionx Implants, Inc. between 1998 and 2003. The busiest year on record is 2001, with 13. The most recent is 2003, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bionx Implants, Inc., by decision year
YearClearances
19984
19996
20003
200113
20023
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K030388IMPACT SUTURE ANCHOR. MODEL 433510HWCSubstantially Equivalent
K023022NUGEN FX SCREWHWCSubstantially Equivalent
K020056DUET SUTURE ANCHORHWCSubstantially Equivalent
K011569BIOSORBFX O/M 2.0/2/4 SYSTEMJEYSubstantially Equivalent
K013546MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214HWCSubstantially Equivalent
K013057BIOCUFF,C, MODELS 236018, 236028, 236036MAISubstantially Equivalent
K012334CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116MAISubstantially Equivalent
K012001SMARTSCREWHWCSubstantially Equivalent
K0120001.5MM BONE FIXATION KITHWCSubstantially Equivalent
K010983PLLA PINHTYSubstantially Equivalent
K010554MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000AHWCSubstantially Equivalent
K003077SMARTSCREW MODEL 222006...227510HWCSubstantially Equivalent
K010687BIOSORBFX AND BIOSORBPDX MESHJEYSubstantially Equivalent
K003659PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260HTYSubstantially Equivalent
K003757THERMOFX MESHJEYSubstantially Equivalent
K003970CONTOUR LABRAL NAIL, MODEL 533520AMAISubstantially Equivalent
K003756BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATESJEYSubstantially Equivalent
K001378BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736MAISubstantially Equivalent
K000836BIOSORBPDX BIOABSORBABLE FIXATION SYSTEMJEYSubstantially Equivalent
K000616SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828MAISubstantially Equivalent
K993074SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525MAISubstantially Equivalent
K993073SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030MAISubstantially Equivalent
K993453MENISCUS ARROW, MODELS 531110, 531113, 531116MAISubstantially Equivalent
K992947CANNULATED SMARTSCREW MODELS 224540C, 224570CHWCSubstantially Equivalent
K992567ANATOMICAL BANKART TACK, MODEL 523520AMAISubstantially Equivalent
K982721BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEMJEYSubstantially Equivalent
K982139BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEMJEYSubstantially Equivalent
K972783BIOFIX BIODEGRADABLE THREADED SUTURE ANCHORMAISubstantially Equivalent
K972919BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREWHWCSubstantially Equivalent
K974876BIONX DISTAL RADIUS SCREWMAISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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