FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
K Number: K012818
·
Decision Nov 20, 2001
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
11
Review Days
90
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Basic Information
- Device Name
- HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
- K Number
- K012818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Triage Medical, Inc.
- Date Received
- August 22, 2001
- Decision Date
- November 20, 2001
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Triage Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062391 | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 | Sep 14, 2006 | Substantially Equivalent |
| 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 |
| K012280 | TITANIUM COMPRESSION ANCHOR SYSTEM MODEL VERSION 2 | Aug 17, 2001 | Substantially Equivalent |