Gap Endo-Exo Medullary System
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- The GAP Nail Endo-Exo Medullary System EUDAMEDGAP ENDO-EXO MEDULLARY SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- Cortical Screw Ø4.0mm X 36mm FDA UDI
- Model / Reference
- GAP-CS4-36 EUDAMEDFDA UDICORTICAL SCREW EUDAMED
- Description
- Cortical Screw Ø4.0mm X 36mm FDA UDI
Identifiers
- Catalog Number
- GAP-CS4-36 FDA UDI
- Primary DI / UDI-DI
- 07540194001504 EUDAMEDFDA UDI
- Basic UDI-DI
- 7540194GAP-SCWQE EUDAMED
- FDA Product Code
- HSB FDA UDI
- EMDN Code
- P09120601 CORTICAL SCREWS EUDAMED
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 36 Millimeter FDA UDIOuter Diameter — 4 Millimeter FDA UDI
Category: Orthopaedic bone screw (non-sliding)
Gap Endo-Exo Medullary System by Orthopediatrics Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw (non-sliding).
- EVOS — Smith & Nephew, Inc. · Class II
- TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Zavation — ZAVATION · Class II
- STARDRIVE — Synthes GmbH · Class IIb
- Arthrex® — Arthrex, Inc. · Class II
- Cancellous Screw, Locking — I.T.S. GmbH · Class II
- PANGEA — Stryker Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (2)
- FDA UDI 39915a1a-673a-424e-86cd-f7d3dfe363ab 37 fields · synced Jun 19, 2026
- EUDAMED 27df595b-0bb9-4a33-b630-fad581eb6cb0 61 fields · synced Jun 19, 2026