FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SCIENT'X CEMENT RESTRICTOR
K Number: K052367
·
Decision Oct 5, 2005
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
53
Applicant Total
12
Review Days
37
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Basic Information
- Device Name
- SCIENT'X CEMENT RESTRICTOR
- K Number
- K052367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Scient'X
- Date Received
- August 29, 2005
- Decision Date
- October 5, 2005
- Product Code
- JDK
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| JDK | Prosthesis, Hip, Cement Restrictor | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Scient'X
| K Number | Device Name | ||
|---|---|---|---|
| K071261 | ISOBAR SEMI-RIGID DUAL DAMPENER | Apr 17, 2008 | Substantially Equivalent |
| K062912 | SCIENT'X SPINAL SYSTEM | Feb 5, 2007 | Substantially Equivalent |
| K052763 | STELLA CERVICAL PLATE | Nov 10, 2005 | Substantially Equivalent |
| K050348 | CO VERTEBRAL BODY REPLACEMENT | May 27, 2005 | Substantially Equivalent |
| K051063 | POLYAXIAL HEMISPHERICAL SPINAL SCREWS | May 23, 2005 | Substantially Equivalent |
| 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 |