FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPUS MAGNUM ANCHOR & INSTRUMENT SET
K Number: K020172
·
Decision Jul 22, 2002
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
13
Review Days
186
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Basic Information
- Device Name
- OPUS MAGNUM ANCHOR & INSTRUMENT SET
- K Number
- K020172
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Opus Medical, Inc.
- Date Received
- January 17, 2002
- Decision Date
- July 22, 2002
- Product Code
- MBI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Opus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042584 | OPUS MINIMAGNUM ANCHOR WITH INSERTER | Dec 14, 2004 | Substantially Equivalent |
| K042914 | OPUS MAGNUM KNOTLESS ANCHOR WITH INSERTER HANDLE | Nov 12, 2004 | Substantially Equivalent |
| K042031 | OPUS SPEEDSTITCH SUTURE DEVICE | Oct 19, 2004 | Substantially Equivalent |
| K041440 | OPUS MAGNUM ANCHOR WITH INSERTER | Jun 25, 2004 | Substantially Equivalent |
| K033317 | SMARTSTITCH M-CONNECTOR, MODEL OM-8700; NEEDLE CASSETTE, OM-8750; AUTOCUFF SYSTEM INSTRUMENT SET, OM-9070 | Dec 30, 2003 | Substantially Equivalent |
| K030170 | REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500 | Jul 28, 2003 | Substantially Equivalent |
| K031083 | OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500 | Jun 12, 2003 | Substantially Equivalent |
| K030235 | F1 DIODE LASER SYSTEM | Apr 23, 2003 | Substantially Equivalent |
| K023843 | SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE | Feb 14, 2003 | Substantially Equivalent |
| K022229 | SMARTSTITCH SUTURE DEVICE, MODEL OM-8500 | Sep 6, 2002 | Substantially Equivalent |