Identity
- Trade Name
- MONARCH FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- MONARCH SPINE SYSTEM PEDICLE SCREW, POLYAXIAL 6.35 x 6.25 x 55mm FDA UDI
- Model / Reference
- 177036255 FDA UDI
- Description
- MONARCH SPINE SYSTEM PEDICLE SCREW, POLYAXIAL 6.35 x 6.25 x 55mm FDA UDI
Identifiers
- Catalog Number
- 177036255 FDA UDI
- Primary DI / UDI-DI
- 10705034054834 FDA UDI
- 510(k) Number
- K010576 FDA UDI
- FDA Product Code
- MNH FDA UDIKWP FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- Not 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
Monarch by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K010576 also covers:
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
- Depuy Spine, Inc.
Sources (1)
- FDA UDI b193c408-0cb3-4e8a-88d5-5eb994684eed 37 fields · synced Jun 8, 2026