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SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM

FDA 510(k) clearance K062789 · decided 2007-02-27

Clearance details

K-number
K062789
Device name
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
Applicant
Synthes (Usa)
Decision
Substantially Equivalent
Date received
2006-09-18
Decision date
2007-02-27
Days to decision
162 days
Clearance type
Traditional
Product code
JEY
Device class
2
Regulation number
872.4760
Medical specialty
Dental
Advisory committee
Dental
Location
West Chester, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fix recall (Z-1918-2016)Synthes (USA) Products LLC2016-06-07
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fix recall (Z-1919-2016)Synthes (USA) Products LLC2016-06-07
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fix recall (Z-1920-2016)Synthes (USA) Products LLC2016-06-07

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