Identity
- Trade Name
- Cervical Interbody Fusion Device FDA UDI
- Generic Name
- Surgical tamp, reusable FDA UDI
- Device Name
- Final Positioner FDA UDI
- Model / Reference
- FP2001 FDA UDI
- Description
- Final Positioner FDA UDI
Identifiers
- Catalog Number
- FP2001 FDA UDI
- Primary DI / UDI-DI
- B565FP20011 FDA UDI
- 510(k) Number
- K123206 FDA UDI
- FDA Product Code
- ODP FDA UDI
- GMDN Term
- Surgical tamp, 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
Category: Surgical tamp, 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 Surgical tamp, reusable.
- nvt — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- MemoFix Super Elastic Nitinol Staple System — Smith & Nephew, Inc. · Class I
- 4WEB Medical — 4Web Medical, Inc. · Class I
- Tornier Radial Head System — TORNIER, INC. · Class I
- RELIANCE — Stryker Corp. · Class I
- nvp — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Life Instruments — Life Instrument Corporation · 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 ee971b22-1984-42a2-bf16-e58d84871385 36 fields · synced Jun 8, 2026