Mikron Makina Sanayi ve Ticaret Ltd. Sti.
Ivedik Ankara, TR
MIKRON MAKINA SANAYI VE TICARET LTD. STI. appears in FDA device records in Ivedik Ankara, TR. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Mikron Makina Sanayi ve Ticaret Ltd. Sti. between 2013 and 2024. The busiest year on record is 2024, with 2. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241657 | MSFX MIKRON SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K240484 | MSFX Mikron Cervical Anterior Plate System | KWQ | Substantially Equivalent | |
| K130073 | MIKRON SPINAL FIXATION SYSTEM, POLYXIAL PEDICLE SCREWS, SET SCREWS, LONGITUDINAL RODS | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010646402 | 3010646402 | MIKRON MAKINA SANAYI VE TICARET LTD. STI. | Agac Isleri Sanayi Sitesi, Ivedik Ankara 06378 TR | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYQAccessories, Fixation, Spinal Intervertebral Body
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HXWBender
- HWWCountersink
- HXZCutter, Wire
- HWBExtractor
- HTJGauge, Depth
- LXIGuide, Drill, Ligament
- HWAImpactor
- HXPInstrument, Bending Or Contouring
- HWNInstrument, Compression
- HAOInstrument, Surgical, Non-Powered
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- HTOReamer
- HXXScrewdriver
- HWXTap, Bone
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- HWKTrephine
- HXCWrench
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain