FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TSRH SPINAL SCREWS
K Number: K932029
·
Decision Jan 20, 1995
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
23
Review Days
633
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Basic Information
- Device Name
- TSRH SPINAL SCREWS
- K Number
- K932029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sofamor Danek Mfg., Inc.
- Date Received
- April 27, 1993
- Decision Date
- January 20, 1995
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
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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 |
| 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 |
| K921256 | LUQUE V SPINAL SYSTEM | May 18, 1993 | Substantially Equivalent for Some Indications |