Identity
- Trade Name
- Monaco Uni-Planar FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Z-Rod, CoCr, 5.5 x 11 x 300mm FDA UDI
- Model / Reference
- 880-5311C FDA UDI
- Description
- Z-Rod, CoCr, 5.5 x 11 x 300mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00843210168876 FDA UDI
- 510(k) Number
- K211027 FDA UDI
- FDA Product Code
- KWQ FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system rod
Monaco Uni-Planar by Altus Spine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system rod.
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
- Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
- The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
- Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II
Cleared under the same submission
K211027 also covers:
- Altus Spine HA Pedicle Screw System — Altus Spine
- Altus Spine HA Pedicle Screw System — Altus Spine
- Altus Spine HA Pedicle Screw System — Altus Spine
- Altus Spine HA Pedicle Screw System — Altus Spine
- Altus Spine HA Pedicle Screw System — Altus Spine
- Altus Spine HA Pedicle Screw System — Altus Spine
- Altus Spine HA Pedicle Screw System — Altus Spine
- Monaco Uni-Planar — Altus Spine
- Monaco Uni-Planar — Altus Spine
- Monaco Uni-Planar — Altus Spine
- Monaco Uni-Planar — Altus Spine
- Monaco Uni-Planar — Altus Spine
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
- Altus Spine
Sources (1)
- FDA UDI a030f464-735d-49b2-9a65-c829389e5df9 35 fields · synced May 31, 2026