G21 SRL

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Bone Cement, Antibiotic (MBB) (5) Arthroscope (HRX) (4) Cement, Bone, Vertebroplasty (NDN) (4) Prosthesis, Hip, Hemi-, Femoral, Metal (KWL) (3) Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (KWY) (3) Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (KWS) (1) Bone Cement (LOD) (1) Curette (HTF) (1)

Premarket Exempt

No Yes

Clear

SpaceFlex Shoulder - 08058964726087 Catalog Number :

Device Description : "Disposable cement spacer molds with metal reinforcement stem are indicated for "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing 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 isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge."

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWS

Prescription Use : Yes

Device Count : 1

SpaceFlex Hip Instrument Kit - 08058964726186 Catalog Number :

Device Description : SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFle SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWY, KWL

Prescription Use : No

Device Count : 1

Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter - 08058964726339 Catalog Number : 900027

Device Description : Kyphoplasty Balloon Catheter

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter - 08058964726407 Catalog Number : 900028

Device Description : Kyphoplasty Balloon Catheter

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

FLEX DRILL 13G - 08058964726742 Catalog Number : 900187

Device Description : Curette with curved distal end used to create a cavity inside the vertebra.

Device Class : 1

Duns Number: 431529195

Premarket Exempt : Yes

Product Code : HTF

Prescription Use : Yes

Device Count : 1

OrthoSteady G - 08058964726759 Catalog Number : 800019

Device Description : Bone Cement

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, LOD

Prescription Use : Yes

Device Count : 1

Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter - 08058964726766 Catalog Number : 900027

Device Description : Kyphoplasty Balloon Catheter

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter - 08058964726773 Catalog Number : 900028

Device Description : Kyphoplasty Balloon Catheter

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

SpaceFlex Hip - 08058964726889 Catalog Number :

Device Description : Disposable custom modular spacer mold

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : KWL, KWY, MBB

Prescription Use : No

Device Count : 1

SpaceFlex Hip - 08058964726896 Catalog Number :

Device Description : Disposable custom modular spacer mold

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, KWY, KWL

Prescription Use : No

Device Count : 1

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