CompressX 101-45028-2
CompressX 101-45028-2 is a Class II device made by Extremity Medical, LLC, cleared under FDA 510(k) K081934 on 29 Aug 2008 and listed in FDA GUDID since 14 Feb 2017 (UDI-DI M78010145028), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM78010145028 | Date14 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK081934 | Date29 Aug 2008 | StatusActive |
Official records
- FDA 510(k) database K081934
Across registries
- FDA 510(k) K081934 decided 29 Aug 2008 Active
- FDA GUDID UDI-DI M78010145028 listed 14 Feb 2017 Listed
Timeline
- Cleared FDA 510(k) K081934
- Listed FDA GUDID M78010145028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CompressX
- Generic name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
- Model / reference
- 101-45028-2
- Primary DI / UDI-DI
- M78010145028
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- FITBONE TAA SYSTEM 1 60000369 by Orthofix, Inc.
- LOCKING CORTICAL SCREW 8161-35-065 816135065 by Biomet Orthopedics, Inc.
- LOCKING CORTICAL SCREW 8163-27-024 816327024 by Biomet Orthopedics, Inc.
- "2.0" SYSTEM 95-2315 by BIOMET MICROFIXATION, INC
- 1MM SYSTEM 01-7402 by BIOMET MICROFIXATION, INC
- ACUMED AT2-S26 by ACUMED LLC
- ACUMED CO-N2338 by ACUMED LLC