Atlas FDA

SYNTHES IN-SITU BENDER/CUTTER

FDA 510(k) clearance K021458 · decided 2002-07-24

Clearance details

K-number
K021458
Device name
SYNTHES IN-SITU BENDER/CUTTER
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2002-05-07
Decision date
2002-07-24
Days to decision
78 days
Clearance type
Abbreviated
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Paoli, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S. recall (Z-0825-2010)Synthes USA (HQ), Inc.2010-02-24
Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes R recall (Z-1248-2009)Synthes Spine2009-06-01
Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes recall (Z-1249-2009)Synthes Spine2009-06-01
In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S Used with Synthes' Rapid R recall (Z-1640-2009)Synthes Spine2009-05-21
In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S. Used with Synthes' Rapi recall (Z-1641-2009)Synthes Spine2009-05-21

PMA approvals by this applicant

RecordFirmDate
NORIAN SRS BONE CEMENT (P970010/S004)Synthes (Usa)2000-08-31
NORIAN SRS CEMENT (P970010/S002)Synthes (Usa)2000-04-28
NORIAN SRS CEMENT (P970010/S001)Synthes (Usa)1999-07-16
NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010)Synthes (Usa)1998-12-23