FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYAXIAL HEMISPHERICAL SPINAL SCREWS
K Number: K051063
·
Decision May 23, 2005
Classifications
1
FEI Numbers
342
Registration Numbers
342
Same Product Code
302
Applicant Total
12
Review Days
27
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Basic Information
- Device Name
- POLYAXIAL HEMISPHERICAL SPINAL SCREWS
- K Number
- K051063
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scient'X
- Date Received
- April 26, 2005
- Decision Date
- May 23, 2005
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | Apr 17, 2008 | Substantially Equivalent |
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| K052763 | STELLA CERVICAL PLATE | Nov 10, 2005 | Substantially Equivalent |
| K052367 | SCIENT'X CEMENT RESTRICTOR | Oct 5, 2005 | Unknown |
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| K043001 | MX POLYAXIAL PEDICLE SCREW | Dec 1, 2004 | Substantially Equivalent |
| K042964 | MX MONOAXIAL PEDICLE SCREW | Nov 22, 2004 | Substantially Equivalent |
| K042317 | CERVICAL PLATE | Sep 24, 2004 | Substantially Equivalent |
| K040747 | ALADYN RIGID SPINE PLATE | Jun 17, 2004 | Substantially Equivalent |
| K040454 | BIOFILL BONE VOID FILLER | May 7, 2004 | Substantially Equivalent |