# Mikron Makina Sanayi Ve Ticaret Ltd. Sti. (manufacturer, Ivedik Ankara, TR): 3 new FDA device listings, incl. screw, fixation, bone

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Mikron Makina Sanayi Ve Ticaret Ltd. Sti. |
| Owner / operator | Mikron Makina Sanayi ve Ticaret Ltd. Sti. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Ivedik Ankara, TR |
| New listings | 3 |
| Devices | Screw, Fixation, Bone; Washer, Bolt Nut; Plate, Fixation, Bone |
| Product codes | HWC, HTN, HRS |
| Device classes | Class II |
| Medical specialties | Orthopedic |
| Brand names | ZT3008035026/LOCKING SELF TAPPING CANCELLOUS SCREW 5,0x26 MM; MX3001001510/LOCKING SELF TAPPING CORTICAL SCREW 1.5X10 MM; MX3009045020/CANNULATED CANCELLOUS HERBERT SCREW 5X20 MM; ZT1021613507/HUMERUS DISTAL POSTEROLATERAL LOCKING PLATE RIGHT 7 HOLES; ZT1021723510/HUMERUS DISTAL MEDIAL LOCKING PLATE LEFT 10 HOLES; ZT1031113505/OLECRANON LOCKING PLATE RIGHT 5 HOLES; ZT3008035054/LOCKING SELF TAPPING CANCELLOUS SCREW 5,0x54 MM; MX3001001528/LOCKING SELF TAPPING CORTICAL SCREW 1.5X28 MM |
| First new listing | 2026-08-31 |
| Latest new listing | 2026-08-31 |
| FDA registration number | 3010646402 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.
