Identity
- Trade Name
- uCentum™ comprehensive posterior system FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Device Name
- Crosslink variable, L, length 78 - 94 mm FDA UDI
- Model / Reference
- CS 3810-04 FDA UDI
- Description
- Crosslink variable, L, length 78 - 94 mm FDA UDI
Identifiers
- Catalog Number
- CS 3810-04 FDA UDI
- Primary DI / UDI-DI
- 04052536080885 FDA UDI
- 510(k) Number
- K123717 FDA UDI
- FDA Product Code
- NKB FDA UDIMNH FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 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
MR Conditional FDA UDI
Category: Bone-screw internal spinal fixation system connector
uCentum™ comprehensive posterior system by Ulrich GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Cleared under the same submission
K123717 also covers:
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
- uCentum™ comprehensive posterior system — Ulrich GmbH & Co. KG
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
- Ulrich GmbH & Co. KG
Sources (1)
- FDA UDI 7507156f-d8c5-4463-92f4-004fc196d3c9 36 fields · synced May 31, 2026