INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER— 510(k) K981193

Name: FDA 510(k) clearance K981193
Creator: U.S. Food and Drug Administration
Published: 1998-06-16

Substantially Equivalent

Innovasive Devices, Inc.

FDA 510(k) clearance K981193 for INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER, Substantially Equivalent on 1998-06-16. Applicant: Innovasive Devices, Inc.. Device class: 2.

Clearance details

Applicant: Innovasive Devices, Inc.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 1998-04-02
Decision date: 1998-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBI

view all

K253065 — Aevumed SUPERCYNCH Button System2026-09-02
K262809 — ArthroTAK Tendon Anchor Kit2026-09-02
K262677 — Iconix Knotless T2026-08-27
K262047 — Grappler Suture Anchor System2026-08-03
K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

More clearances from Innovasive Devices, Inc.

view all

K994269 — TITAN RC TACK2000-01-10
K993975 — ABSOLUTE ABSORBABLE INTERFERENCE SCREW1999-12-20
K992458 — RC MULTISUTURE BONE ANCHOR, MODEL 4453/44541999-10-14
K992377 — RC TACK1999-10-08
K990454 — BIO-INTERFERENCE SCREW1999-07-01

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.