FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DANEK TISSUE RESECTING SYSTEM
K Number: K925577
·
Decision Apr 8, 1993
Classifications
1
FEI Numbers
386
Registration Numbers
386
Same Product Code
680
Applicant Total
23
Review Days
156
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DANEK TISSUE RESECTING SYSTEM
- K Number
- K925577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.1100
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sofamor Danek Mfg., Inc.
- Date Received
- November 3, 1992
- Decision Date
- April 8, 1993
- Product Code
- HRX
- 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 |
|---|---|---|---|
| HRX | Arthroscope | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRX), ordered by most recent decision date.
Digital ClarusScope System and Digital NeuroPEN System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom DS Decompression System
FDA 510(k)
FDA Class 2
·Orthopedic
VantageTM Lumbar Decompression Kit
FDA 510(k)
FDA Class 2
·Orthopedic
MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
FDA 510(k)
FDA Class 2
·Orthopedic
PUREVUE FMS
FDA 510(k)
FDA Class 2
·Orthopedic
Articulator Arthroscopic Bur
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Sofamor Danek Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K936294 | SENTRY(TM) ANTERIOR/POSTERIOR SPINAL SYSTEMS | Dec 19, 1995 | Substantially Equivalent for Some Indications |
| K930191 | DANEK(TM) SPINAL EPIDURAL ENDOSCOPIC SY | Sep 26, 1995 | Substantially Equivalent |
| K932029 | TSRH SPINAL SCREWS | Jan 20, 1995 | Substantially Equivalent |
| K922486 | DANEK TISSUE CUTTING AND REMOVAL SYSTEM | Oct 12, 1993 | Substantially Equivalent for Some Indications |
| K930807 | SENTRY ANTERIOR SPINAL SYSTEM | Oct 1, 1993 | Substantially Equivalent |
| K930710 | SENTRY POSTERIOR SPINAL SYSTEM | Oct 1, 1993 | Substantially Equivalent |
| K923242 | CROSSLINK AXIAL AND OFFSET PLATES | May 19, 1993 | Substantially Equivalent for Some Indications |
| K922543 | Z-PLATE ANTERIOR FIXATION SYSTEM | May 19, 1993 | Substantially Equivalent for Some Indications |
| K922672 | AUGMENT POSTERIOR SPINAL FIXATION SYSTEM | May 18, 1993 | Substantially Equivalent for Some Indications |
| K925811 | TSRH CENTRAL POST HOOKS | May 18, 1993 | Substantially Equivalent for Some Indications |