Identity
- Trade Name
- RemeOs™ Screw LAG Solid FDA UDI
- Generic Name
- Bioabsorbable orthopaedic bone screw FDA UDI
- Device Name
- RemeOs™ Screw LAG Solid 3.5 mm x 36 mm FDA UDI
- Model / Reference
- B-FSL-3536 FDA UDI
- Description
- RemeOs™ Screw LAG Solid 3.5 mm x 36 mm FDA UDI
Identifiers
- Catalog Number
- B-FSL-3536 FDA UDI
- Primary DI / UDI-DI
- 06438394015456 FDA UDI
- 510(k) Number
- DEN220030 FDA UDI
- FDA Product Code
- QJD FDA UDI
- GMDN Term
- Bioabsorbable orthopaedic bone screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3041 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Width — 3.5 Millimeter FDA UDILength — 36 Millimeter FDA UDI
Category: Bioabsorbable orthopaedic bone screw
RemeOs™ Screw LAG Solid by Bioretec Oy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioabsorbable orthopaedic bone screw.
- MILAGRO — DePuy Mitek, Inc. · Class II
- MILAGRO — Medos International Sàrl · Class II
- 1.5 mm Inion CPS® Baby — Inion , Ltd. · Class II
- Inion Hexalon™ — Inion , Ltd. · Class II
- 2.0 mm Inion CPS® — Inion , Ltd. · Class II
- Arthrex® — Arthrex, Inc. · Class II
- MILAGRO — Medos International Sàrl · Class II
- REUNITE SCREW SYSTEM — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
DEN220030 also covers:
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
- Bioretec Oy
Sources (1)
- FDA UDI 5d2c3c14-c981-4bb0-93dd-5afba69e7886 36 fields · synced Jun 1, 2026