G21 SRL

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Filters

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) (4) Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer (JWH) (3) Prosthesis, Hip, Hemi-, Femoral, Metal (KWL) (1) Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented (KWY) (1)

Premarket Exempt

No Yes

Clear

SpaceFlex Hip - 08058964726902 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 Knee - 08058964726933 Catalog Number :

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, JWH

Prescription Use : No

Device Count : 1

SpaceFlex Knee - 08058964726940 Catalog Number :

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, JWH

Prescription Use : No

Device Count : 1

SpaceFlex Knee - 08058964727039 Catalog Number :

Device Description : Orthopedic bone cement modular spacer for temporary knee prosthesis

Device Class : 2

Duns Number: 431529195

Premarket Exempt : No

Product Code : MBB, JWH

Prescription Use : No

Device Count : 1

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