Search Results
Found 3 results
510(k) Data Aggregation
K Number
K962757Device Name
J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
Manufacturer
J.B.S., S.A.
Date Cleared
1996-09-25
(71 days)
Product Code
MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
J.B.S., S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When wed as a non cervical hook and sarel services in indicated for we in prisents with degenerative discover (discosenic back pain with deserentian of the discomplies to racked studies), spondegical sociosis, spinel starts spinel starts with winnely falled back suppens, and frances. Villem wed as credicte screens (a) lawing sever sports (a) lawing sever sport 4) at the L.S.S) joint, , who are receiving fusion using anto cone watt only, (c) who are having the device for attacked to the lumber and (d) who are lasing the clerine "tenoved after development of a stid fision mess The simple, is intended for ossein five levels 17 through S. The Searl Pares are interned for posterior sacral fixation at S1 and S2. Levels of pedicle screw fivation are posterior from levels L3 to through S1 only.
Device Description
The J.S.Spine System @ inplans are station of the stablic the hunter and torners were to promote insion. The System is to be removed aller fision occurs. The JBS. Spine Systems, sazal plates, pedicle screws, reds, pedicle and laminer hooks and linking plates. J.B.S. has both firm rod systems. The inqlant are composed of surgical implant timinon, T.6ALAVELL, accoming to ASTM-136-92. Instruments to implat the IB.S. Spine System are made of ZOC'l stainless steel source to ATM grace 400 staries see) with a polyna handle, ar surgical implant titanium, Ti 6Al 4V EI I .
Ask a Question
K Number
K955864Device Name
J.B. S. C1-C2 CLAMP
Manufacturer
J.B.S., S.A.
Date Cleared
1996-03-15
(79 days)
Product Code
KWP
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
J.B.S., S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fixation of C1-C2 in case of fracture or multi-operated back.
Device Description
The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
Ask a Question
K Number
K953881Device Name
SPINE SYSTEM SACRAL PLATE
Manufacturer
J.B.S., S.A.
Date Cleared
1996-02-21
(187 days)
Product Code
MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
J.B.S., S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1