Identity
- Trade Name
- Cervical Interbody Fusion Device FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- Cervical RASP 9 mm FDA UDI
- Model / Reference
- CR1517-09 FDA UDI
- Description
- Cervical RASP 9 mm FDA UDI
Identifiers
- Catalog Number
- CR1517-09 FDA UDI
- Primary DI / UDI-DI
- B565CR1517091 FDA UDI
- 510(k) Number
- K123206 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Height — 9 Millimeter FDA UDI
Category: Bone file/rasp, manual, reusable
Cervical Interbody Fusion Device by Maxim Surgical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone file/rasp, manual, reusable.
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- NORDENT MANUFACTURING INC — NORDENT MANUFACTURING INC · Class I
- Life Instruments — Life Instrument Corporation · Class I
- TALOS®-C — MEDITECH SPINE, LLC · Class II
- DeGen Standard Instrumentation — Degen Medical · Class I
- TiWave C Cervical Cage System — Kalitec Direct LLC · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- 4WEB Medical — 4Web Medical, Inc. · Class I
Cleared under the same submission
K123206 also covers:
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
- Cervical Interbody Fusion Device — Maxim Surgical
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
- Maxim Surgical
Sources (1)
- FDA UDI a6da90b5-623b-463b-aa1c-d94dcfd671f0 37 fields · synced May 30, 2026