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No Description
G21 SRL
VV 11 120 5
In Commercial Distribution
- 08058964725356 ()
- Vertebral body cement cannula
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a
temporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stage
revision procedure due to a septic process.
The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone
cement and inserted into the humeral medullary canal and glenoid cavity of the shoulder
following removal of the existing humeral and glenoideal cavity implants and debridement.
SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy
(standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds is
not intended for use more than 180 days, at which time it must be explanted and permanent
devices implanted or another appropriate treatment performed (e.g. resection arthroplasty,
fusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low
viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated
for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete
scientific and anatomical knowledge.
G21 SRL
900001 084215
In Commercial Distribution
- 08058964724977 ()
- Orthopaedic cement spacer mould
No Description
G21 SRL
VV 13 120 5
In Commercial Distribution
- 08058964724687 ()
- Vertebral body cement cannula
Bone Cement Closed Mixing System
G21 SRL
900122
In Commercial Distribution
- 08058964724670 ()
- Orthopaedic cement preparation/delivery kit
Mixing System and Delivery Syringes
G21 SRL
900129
In Commercial Distribution
- 08058964724564 ()
- Orthopaedic cement preparation/delivery kit
No Description
G21 SRL
900141
In Commercial Distribution
- 08058964724427 ()
- Bone access channel kit
No Description
G21 SRL
900103
In Commercial Distribution
- 08058964724113 ()
- Vertebral body cement cannula
No Description
G21 SRL
900100
In Commercial Distribution
- 08058964724083 ()
- Vertebral body cement cannula
No Description
G21 SRL
900097
In Commercial Distribution
- 08058964724052 ()
- Vertebral body cement cannula
No Description
G21 SRL
900094
In Commercial Distribution
- 08058964724021 ()
- Vertebral body cement cannula