FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
K Number: K944560
·
Decision Oct 18, 1994
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
288
Applicant Total
39
Review Days
32
Basic Information
- Device Name
- MAN SURG INSTR/ACCESS TO KLS-MARTIN MICRO OSTEO SYST
- K Number
- K944560
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KLS-MARTIN L.P.
- Date Received
- September 16, 1994
- Decision Date
- October 18, 1994
- Product Code
- JEY
- 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 |
|---|---|---|---|
| JEY | Plate, Bone | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JEY), ordered by most recent decision date.
KLS Martin Oral-Max Implants MR Conditional (bundled)
FDA 510(k)
FDA Class 2
·Dental
MRI Universal
FDA 510(k)
FDA Class 2
·Dental
tmCMF Solution
FDA 510(k)
FDA Class 2
·Dental
METICULY Patient-specific titanium maxillofacial mesh implant
FDA 510(k)
FDA Class 2
·Dental
Stryker Facial iD System
FDA 510(k)
FDA Class 2
·Dental
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by KLS-MARTIN L.P.
| K Number | Device Name | ||
|---|---|---|---|
| K210741 | KLS Martin Neuro Rongeurs | Jun 3, 2022 | Substantially Equivalent |
| K153482 | KLS Martin Thoracic Plating System | Apr 6, 2016 | Substantially Equivalent |
| K133304 | RXG DISTRACTION SYSTEM | May 15, 2014 | Substantially Equivalent |
| K121606 | RESORB-X G | Jan 17, 2013 | Substantially Equivalent |
| K112064 | RESORB X-G | Mar 23, 2012 | Substantially Equivalent |
| K080862 | SONICWELD RX (RESORB-X) | Jul 21, 2008 | Substantially Equivalent |
| K072707 | PATIENT CONTOURED MESH-PEEK (PCM-P) | Dec 19, 2007 | Substantially Equivalent |
| K062570 | PATIENT CONTOURED MESH (PCM) | Oct 31, 2006 | Substantially Equivalent |
| K061507 | SONICWELD RX ENDOBROW FIXATION | Sep 21, 2006 | Substantially Equivalent |
| K051165 | KLS MARTIN STERNAL TALON | Sep 7, 2006 | Substantially Equivalent |