Atlas FDA

SYNFIX-LR SPACER

FDA 510(k) clearance K072253 · decided 2007-10-12

Clearance details

K-number
K072253
Device name
SYNFIX-LR SPACER
Applicant
Synthes Spine Co.Lp
Decision
Substantially Equivalent
Date received
2007-08-14
Decision date
2007-10-12
Days to decision
59 days
Clearance type
Traditional
Product code
OVD
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
West Chester, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231. The recall (Z-0931-2009)Synthes Spine2009-01-30