FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
K Number: K062391
·
Decision Sep 14, 2006
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
77
Applicant Total
11
Review Days
29
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Basic Information
- Device Name
- DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
- K Number
- K062391
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Triage Medical, Inc.
- Date Received
- August 16, 2006
- Decision Date
- September 14, 2006
- Product Code
- MRW
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | FDA unclassified | Unknown |
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Other Clearances by Triage Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K052043 | 3.8MM CS FACET COMPRESSION DEVICE | Oct 17, 2005 | Substantially Equivalent |
| K051949 | 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 | Aug 5, 2005 | Substantially Equivalent |
| K043351 | 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N | Feb 18, 2005 | Substantially Equivalent |
| K042244 | BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE | Sep 16, 2004 | Substantially Equivalent |
| K040250 | BONE-LOK HP WASHER | Mar 23, 2004 | Substantially Equivalent |
| K014304 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR, MODEL BMCD-35-3050S | Mar 27, 2002 | Substantially Equivalent |
| K014243 | BONE-LOK BIOABSORBABLE COMPRESSION ANCHOR WITH TITANIUM FIXTURE , MODEL BMCD-35-3040, MBCD-35-4050 | Mar 26, 2002 | Substantially Equivalent |
| K012817 | HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED | Nov 20, 2001 | Substantially Equivalent |
| K012818 | HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX | Nov 20, 2001 | Substantially Equivalent |
| K012280 | TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 | Aug 17, 2001 | Substantially Equivalent |