Identity
- Trade Name
- MONARCH FDA UDI
- Generic Name
- Bone approximation clamp FDA UDI
- Device Name
- MONARCH SPINE SYSTEM RATCHETING ROD CLAMP 6.35mm FDA UDI
- Model / Reference
- 277030120 FDA UDI
- Description
- MONARCH SPINE SYSTEM RATCHETING ROD CLAMP 6.35mm FDA UDI
Identifiers
- Catalog Number
- 277030120 FDA UDI
- Primary DI / UDI-DI
- 10705034196633 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone approximation clamp FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
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
Monarch by Depuy Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 6dea3700-9350-4f77-972e-132b9e5a3069 36 fields · synced May 31, 2026