Atlas FDA

EBI PERIARTICULAR PLATING SYSTEM

FDA 510(k) clearance K042237 · decided 2004-09-16

Clearance details

K-number
K042237
Device name
EBI PERIARTICULAR PLATING SYSTEM
Applicant
Ebi, L.P.
Decision
Substantially Equivalent
Date received
2004-08-18
Decision date
2004-09-16
Days to decision
29 days
Clearance type
Traditional
Product code
HRS
Device class
2
Regulation number
888.3030
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Parsippany, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsip recall (Z-2290-2009)EBI, L.P.2009-09-22
Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsip recall (Z-2291-2009)EBI, L.P.2009-09-22
Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsip recall (Z-2292-2009)EBI, L.P.2009-09-22
Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany recall (Z-2293-2009)EBI, L.P.2009-09-22
Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany recall (Z-2294-2009)EBI, L.P.2009-09-22
Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany recall (Z-2295-2009)EBI, L.P.2009-09-22
Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only Biomet, 100 Interpace Parkway, Parsip recall (Z-2296-2009)EBI, L.P.2009-09-22
Bone Screw .5MM X 60MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany, recall (Z-2297-2009)EBI, L.P.2009-09-22
Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany recall (Z-2298-2009)EBI, L.P.2009-09-22
Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only Biomet, 100 Interpace Parkway, Parsippany, recall (Z-2299-2009)EBI, L.P.2009-09-22

PMA approvals by this applicant

RecordFirmDate
SCOLITRON(TM) STIMULATOR (P820008/S005)Ebi, L.P.1987-04-02
SCOLITRON(TM) STIMULATOR (P820008/S004)Ebi, L.P.1987-01-07
SCOLITRON(TM) STIMULATOR (P820008/S003)Ebi, L.P.1986-09-12
SCOLITRON(TM) STIMULATOR (P820008/S002)Ebi, L.P.1986-01-17
SCOLITRON(TM) STIMULATOR (P820008/S001)Ebi, L.P.1983-06-14
SCOLITRON(TM) STIMULATOR (P820008)Ebi, L.P.1983-01-06