FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
K Number: K030958
·
Decision Nov 20, 2003
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
22
Review Days
238
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Basic Information
- Device Name
- ORIA SPINAL SYSTEM, DOMINO AND TUBE CONNECTORS
- K Number
- K030958
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ortho Tec, LLC
- Date Received
- March 27, 2003
- Decision Date
- November 20, 2003
- Product Code
- MNI
- 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 |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | FDA class 2 | Orthopedic |
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Other Clearances by Ortho Tec, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K040514 | EOVIA CALCIUM PHOSPHATE CERAMIC | May 3, 2004 | Substantially Equivalent |
| K040346 | MODIFICATION TO ORIA TOP CLIP SYSTEM | Mar 12, 2004 | Substantially Equivalent |
| K031471 | ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 | Oct 10, 2003 | Substantially Equivalent |
| K023884 | MODIFICATION ORIA SPINAL SYSTEM | Aug 20, 2003 | Substantially Equivalent |
| K023378 | ORIA CLARIS | Jun 27, 2003 | Substantially Equivalent |
| K031452 | ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 | Jun 18, 2003 | Substantially Equivalent |
| K030500 | ORIA ZENITH | Mar 20, 2003 | Substantially Equivalent |
| K023377 | ORIA CERVICAL PLATES | Mar 4, 2003 | Substantially Equivalent |
| K030253 | ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06 | Feb 21, 2003 | Substantially Equivalent |
| K030252 | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) | Feb 21, 2003 | Substantially Equivalent |