FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
K Number: K990637
·
Decision Oct 22, 1999
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
6
Applicant Total
402
Review Days
238
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
- SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
- K Number
- K990637
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synthes (Usa)
- Date Received
- February 26, 1999
- Decision Date
- October 22, 1999
- Product Code
- NEI
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| NEI | Prosthesis, Condyle, Mandibular, Temporary | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEI), ordered by most recent decision date.
STRYKER TEMPORARY CONDYLAR PROSTHESIS
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
FDA 510(k)
FDA Class 2
·Dental
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
FDA 510(k)
FDA Class 2
·Dental
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
ADD-ON CONDYLE
FDA 510(k)
FDA Class 2
·Dental
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Synthes (Usa)
| K Number | Device Name | ||
|---|---|---|---|
| K131984 | SYNTHES SYNSONIC ULNA NAIL | Mar 31, 2014 | Substantially Equivalent |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Dec 5, 2011 | Substantially Equivalent |
| K111540 | SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM | Aug 8, 2011 | Substantially Equivalent |
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM | Jul 28, 2011 | Substantially Equivalent |
| K103002 | SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM | Mar 2, 2011 | Substantially Equivalent |
| K103243 | 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM | Jan 21, 2011 | Substantially Equivalent |
| K102656 | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM | Dec 20, 2010 | Substantially Equivalent |
| K093299 | SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM | Dec 16, 2010 | Substantially Equivalent |
| K102694 | 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES | Dec 9, 2010 | Substantially Equivalent |
| K100776 | SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM | Aug 3, 2010 | Substantially Equivalent |