Atlas FDA

ALLOCRAFT DBM

FDA 510(k) clearance K052735 · decided 2005-12-28

Clearance details

K-number
K052735
Device name
ALLOCRAFT DBM
Applicant
Lifecell Corp.
Decision
Substantially Equivalent
Date received
2005-09-30
Decision date
2005-12-28
Days to decision
89 days
Clearance type
Traditional
Product code
MBP
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Washington, DC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corpora recall (Z-1298-2008)LifeCell Corporation2008-03-26
AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , D recall (Z-1299-2008)LifeCell Corporation2008-03-26