6173.1505
Ref 6173.1505
6173.1505 is a Class I device made by Globus Medical, Inc., registered in EUDAMED on 23 Jun 2026 (Basic UDI-DI 0193982INSTRUMENTSKC) with CE/MDR certificate 1000315034 valid until 14 May 2029 and listed in FDA GUDID since 10 Jul 2019 (UDI-DI 00889095717662), active as of 22 Oct 2026.
Active
CE MDR
Valid until
14 May 2029
FDA recalls
Not checked
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0193982INSTRUMENTSKC 00889095717662 | Date23 Jun 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00889095717662 | Date10 Jul 2019 | StatusListed |
Official records
- EUDAMED public site 0193982INSTRUMENTSKC
- AccessGUDID record 00889095717662
Across registries
- EUDAMED Basic UDI-DI 0193982INSTRUMENTSKC registered 23 Jun 2026 Active
- FDA GUDID UDI-DI 00889095717662 listed 10 Jul 2019 Listed
Certificates
- 1000315034 Active
Quality management system EU MDR
- Certifier
- DQS Medizinprodukte GmbH 0297
- Issued
- 10 Jun 2026
- Expires
- 14 May 2029
- Reason
- Add device or group
Timeline
- Listed FDA GUDID 00889095717662
- Certificate issued EUDAMED 1000315034
- Registered EUDAMED 0193982INSTRUMENTSKC
- Certificate expires EUDAMED 1000315034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- ARBOR External Fixation
- Generic name
- Fluted surgical drill bit, reusable
- Device name
- Reusable Instruments
- Model / reference
- 6173.1505
- Primary DI / UDI-DI
- 00889095717662
- Basic UDI-DI
- 0193982INSTRUMENTSKC
- Direct marketing DI
- 00889095717662
- FDA product code
- LXH
- EMDN code
- L0999 Orthopaedic and traumatological surgery instruments, reusable - other
- GMDN term
- Fluted surgical drill bit, reusable
- Device class
- Class I
- Regulation number
- 888.4540
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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