FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEEK CAS
K Number: K050861
·
Decision May 27, 2005
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
276
Applicant Total
39
Review Days
52
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Basic Information
- Device Name
- PEEK CAS
- K Number
- K050861
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3060
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interpore Cross Intl.
- Date Received
- April 5, 2005
- Decision Date
- May 27, 2005
- Product Code
- MQP
- 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 |
|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | FDA class 2 | Orthopedic |
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Other Clearances by Interpore Cross Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K031399 | INTERGRO DBM | Feb 18, 2005 | Substantially Equivalent |
| K041407 | TITANIUM MESH IMPLANT | Dec 29, 2004 | Substantially Equivalent |
| K043229 | MODIFICATION TO ALTIUS OCT SYSTEM | Dec 21, 2004 | Substantially Equivalent |
| K042798 | C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM | Nov 4, 2004 | Substantially Equivalent |
| K040928 | EXPANDABLE PEEK VBR IMPLANT | Aug 27, 2004 | Substantially Equivalent |
| K041794 | C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM | Jul 19, 2004 | Substantially Equivalent |
| K041449 | SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SEAT | Jul 1, 2004 | Substantially Equivalent |
| K033961 | ALTIUS OCT SYSTEM | Apr 14, 2004 | Substantially Equivalent |
| K040168 | MODIFICATION TO GEO STRUCTURE | Apr 8, 2004 | Substantially Equivalent |
| K031772 | TI FENESTRATED PLATE | Sep 5, 2003 | Substantially Equivalent |