510(k) clearances

Newclip Patient-matched instrumentation non sterile PSI

Newclip Technics · Orthopedic

K243912Substantially EquivalentTraditionalPBF
Open FDA's page for this record
Third party flag
N
City
Haute Goulaine
Advisory committee description
Orthopedic
Address 1
Pa De La Lande Saint Martin
Address 2
45 Rue Des Garottières
Statement or summary
Summary
Product code
PBF
Zip code
44115
Applicant
Newclip Technics
Decision date
2025-02-13
Decision code
SESE
Country code
FR
Device name
Newclip Patient-matched instrumentation non sterile PSI
Advisory committee
OR
Contact
Gaëlle Gourbiere
K number
K243912
Date received
2024-12-19
Review advisory committee
OR
Postal code
44115
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Orthopaedic Surgical Planning And Instrument Guides
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
3009555447, 3036756245, 1822565, 9617840, 3012916784, 3009196021, 8043792, 3016090213, 3019248313, 3009555440, 1724955, 3007366790, 3005180920, 3008110533, 3030409224, 1020279, 3006946276, 1043534, 3021635140, 3008650117, 3013561205, 3005718816, 3010407203, 3014483751, 3038011206, 3011623994, 1057946, 3010163695, 9610905, 3033509898, 3007143290, 3003998208, 3010667733, 3012086398, 3025603301, 3014273501, 3027329005
FEI number
3009555447, 3036756245, 3002807464, 3012916784, 3009196021, 3016090213, 3019248313, 3009555440, 3003142829, 3005180920, 3008110533, 1000525271, 3030409224, 3002808269, 1020279, 3006946276, 1043534, 3007282753, 3021635140, 3008650117, 3013561205, 3005718816, 3010407203, 3014483751, 3038011206, 3011623994, 3010163695, 3033509898, 3007143290, 3003998208, 1000220733, 3010667733, 3012086398, 3025603301, 3003714383, 3014273501, 3027329005
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.