Identity
- Trade Name
- MONARCH FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- MONARCH SPINE SYSTEM WASHER, POLYAXIAL FDA UDI
- Model / Reference
- 177091080 FDA UDI
- Description
- MONARCH SPINE SYSTEM WASHER, POLYAXIAL FDA UDI
Identifiers
- Catalog Number
- 177091080 FDA UDI
- Primary DI / UDI-DI
- 10705034059808 FDA UDI
- 510(k) Number
- K024348 FDA UDI
- FDA Product Code
- KWP FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Implantable bone washer
Monarch by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
- Monster Screw System — Paragon 28 · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · Class II
- FacetLink System — WALDEMAR LINK GmbH & Co. KG · U
Cleared under the same submission
K024348 also covers:
- MONARCH — Depuy Spine, Inc.
- MONARCH — Depuy Spine, Inc.
- MONARCH — Depuy Spine, Inc.
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
- MONARCH — Medos International Sàrl
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 d88ba5b0-619a-44ec-a7f1-b0dd4b6d4339 36 fields · synced May 31, 2026