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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K130274

BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM · Elite Surgical Supplies (Pty), Ltd. · decided 2013-10-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
BiolignTL301607-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009708071446
Biolign SCR041427ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696225470
BiolignTL301607-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226668
BiolignTL361609-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226743
Biolign BCC150810ELITE SURGICAL SUPPLIES (PTY) LTDODP06009696226019
BiolignTL301606-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009708071439
Biolign SCN041802ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696226538
Biolign SCT75014ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696226491
Biolign TL361606-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696222929
Biolign TL361609-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226620
Biolign BCC180406ELITE SURGICAL SUPPLIES (PTY) LTDODP06009696222899
Biolign TL361611-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226767
Biolign TL361606-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226590
Biolign SCN041602ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696226521
Biolign SCR041627ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696226552
BiolignSCN041402ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696226514
BiolignTL301606-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009708071477
BiolignTL301612-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226712
Biolign TL361611-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226644
Biolign BCC180507ELITE SURGICAL SUPPLIES (PTY) LTDODP06009696222905
Biolign TL301611-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226705
BiolignTL361607-10ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696222561
Biolign SCT95014ELITE SURGICAL SUPPLIES (PTY) LTDOVE06009696225814
Biolign TL361607-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226606
BiolignTL361612-05ELITE SURGICAL SUPPLIES (PTY) LTDMAX06009696226651