PEBA ANCHOR/SUTURE COMBINATION

Fastener, Fixation, Nondegradable, Soft Tissue

ORTHOPAEDIC BIOSYSTEMS, LTD.

The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Peba Anchor/suture Combination.

Pre-market Notification Details

Device IDK972326
510k NumberK972326
Device Name:PEBA ANCHOR/SUTURE COMBINATION
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale,  AZ  85260
ContactJeffrey B Skiba
CorrespondentJeffrey B Skiba
ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 Scotsdale,  AZ  85260
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-23
Decision Date1998-02-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03596010619112 K972326 000
03596010502438 K972326 000
03596010502421 K972326 000
03596010502414 K972326 000
03596010495457 K972326 000
03596010495440 K972326 000
03596010495433 K972326 000
03596010495426 K972326 000
03596010485670 K972326 000
03596010485663 K972326 000
03596010485656 K972326 000
00885554014686 K972326 000
00885554014136 K972326 000
03596010502445 K972326 000
03596010505125 K972326 000
03596010585998 K972326 000
03596010584465 K972326 000
03596010581044 K972326 000
03596010581037 K972326 000
03596010581020 K972326 000
03596010581013 K972326 000
03596010533845 K972326 000
03596010533838 K972326 000
03596010533821 K972326 000
03596010532213 K972326 000
03596010532206 K972326 000
03596010532190 K972326 000
00885554012835 K972326 000

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.