Identity
- Trade Name
- aprevo FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
- Device Name
- aprevo M4L Inserter FDA UDI
- Model / Reference
- 1090 FDA UDI
- Description
- aprevo M4L Inserter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810056991326 FDA UDI
- 510(k) Number
- K243802 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Category: Orthopaedic inorganic implant inserter/extractor, single-use
aprevo by Carlsmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic inorganic implant inserter/extractor, single-use.
- Shukla Winquist 3 - MKS1017 — Shukla Medical · Class I
- RIPTIDE — Tyber Medical · Class I
- Shukla Nail-BR S9NAIL-BR — Shukla Medical · Class I
- Shukla Acetabular Cup - S9CUP — Shukla Medical · Class I
- Shukla Hip S9HIP — Shukla Medical · Class I
- 3.5 X 15.5mm Citrefix XPress System — ACUITIVE TECHNOLOGIES · Class II
- Shukla Nail S9NAIL — Shukla Medical · Class I
- restor3d Disposable Instrument, Wedge — Restor3D · Class I
Cleared under the same submission
K243802 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carlsmed, Inc.
Sources (1)
- FDA UDI ce30687d-03df-46de-96ba-1520927f7ab1 34 fields · synced May 30, 2026