FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
K Number: K993808
·
Decision Dec 6, 1999
Classifications
1
FEI Numbers
326
Registration Numbers
326
Same Product Code
308
Applicant Total
39
Review Days
26
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SYNERGY INTEGRAL SCREWS, MODEL NUMBERS 2161,2162,2163,2164,2165,2166,2167,2168,2169,2210,2211,2212,2215,2216,2217,2220
- K Number
- K993808
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Interpore Cross Intl.
- Date Received
- November 10, 1999
- Decision Date
- December 6, 1999
- Product Code
- MNH
- 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 |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNH), ordered by most recent decision date.
Reliance Spinal Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
CastleLoc Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
FixxSure® X-Link
FDA 510(k)
FDA Class 2
·Orthopedic
Spinal fixation system
FDA 510(k)
FDA Class 2
·Orthopedic
ANAX 5.5 Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
HC Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Interpore Cross Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K050861 | PEEK CAS | May 27, 2005 | Substantially Equivalent |
| 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 |