510(k) clearances

3DMatrix Surgical Mesh

Printbio, Inc. · General, Plastic Surgery

K232602Substantially EquivalentTraditionalOXF
Open FDA's page for this record
Third party flag
N
City
Long Island City
Advisory committee description
General, Plastic Surgery
Address 1
51-36 35th St.
Statement or summary
Summary
Product code
OXF
Zip code
11101
Applicant
Printbio, Inc.
Decision date
2024-05-23
Decision code
SESE
Country code
US
Device name
3DMatrix Surgical Mesh
Advisory committee
SU
Contact
Kevin Slawin
K number
K232602
State
NY
Date received
2023-08-28
Review advisory committee
SU
Postal code
11101
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery
Medical specialty description
General, Plastic Surgery
Regulation number
878.3300
Device class
2
Registration number
3002719998, 3002924436, 3003910212, 3006017180, 1319639, 3012429393, 3004681519
FEI number
3002719998, 3002924436, 1000138054, 3003910212, 3003870583, 3006017180, 3012429393
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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.