OPUS MAGNUM ANCHOR & INSERTER— 510(k) K012125
Substantially EquivalentOpus Medical, Inc.
FDA 510(k) clearance K012125 for OPUS MAGNUM ANCHOR & INSERTER, Substantially Equivalent on 2001-09-17. Applicant: Opus Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Opus Medical, Inc.
- Product code
- Code HTY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Juan Capistrano, CA, US
Recent devices under product code HTY
view allMore clearances from Opus Medical, Inc.
view all- K042584 — OPUS MINIMAGNUM ANCHOR WITH INSERTER
- K042914 — OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE
- K042031 — OPUS SPEEDSTITCH SUTURE DEVICE
- K041440 — OPUS MAGNUM ANCHOR WITH INSERTER
- K033317 — SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070
Adverse events under product code HTY
product code HTY- Injury
- 544
- Total
- 544
Source: openFDA MAUDE database, through . 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.