PEBA ANCHOR (MULTIPLE SIZES)— 510(k) K951451

Name: FDA 510(k) clearance K951451
Creator: U.S. Food and Drug Administration
Published: 1995-10-31

Substantially Equivalent for Some Indications

Orthopaedic Biosystems, Ltd.

FDA 510(k) clearance K951451 for PEBA ANCHOR (MULTIPLE SIZES), Substantially Equivalent for Some Indications on 1995-10-31. Applicant: Orthopaedic Biosystems, Ltd.. Device class: 2.

Clearance details

Applicant: Orthopaedic Biosystems, Ltd.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1995-03-29
Decision date: 1995-10-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Scotsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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K982996 — POLYMER OBL SB ANCHOR / SUTURE COMBINATION1999-03-04
K983169 — POLYMER THREADED ANCHOR1998-12-16
K982963 — POLYMER THREADED ANCHOR / SUTURE COMBINATION1998-11-20
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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.