Identity
- Trade Name
- Kompressor™ Compression Screw System FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites. FDA UDI
- Model / Reference
- 210420 FDA UDI
- Description
- The standard Kompressor Compression Screw is a two-piece fixation device intended for the use in the reduction, stabilization, and internal fixation of bone fractures. The 2-piece design incorporates the use of a leading and trailing screw component. The implant utilizes a variance in thread pitch between the leading and trailing portions of the screw to reduce and fix fracture fragments, and is available in a variety of sizes to accommodate various fracture types and sites. FDA UDI
Identifiers
- Catalog Number
- 210420 FDA UDI
- Primary DI / UDI-DI
- 10381780065616 FDA UDI
- 510(k) Number
- K040356 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Kompressor™ Compression Screw System by Ascension Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI f24bd50f-6cd8-4bfe-8954-4effafc9b787 39 fields · synced Jun 1, 2026