Identity
- Trade Name
- SCREW SYSTEM FDA UDI
- Generic Name
- Shoulder prosthesis screw FDA UDI
- Model / Reference
- 113846 FDA UDI
Identifiers
- Catalog Number
- 113846 FDA UDI
- Primary DI / UDI-DI
- 00880304213975 FDA UDI
- FDA Product Code
- KWS FDA UDIKWT FDA UDILPH FDA UDIMBF FDA UDIHSD FDA UDI
- GMDN Term
- Shoulder prosthesis screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI888.3650 FDA UDI888.3358 FDA UDI888.3670 FDA UDI888.3690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Shoulder prosthesis screw
Screw System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K030710 also covers:
- ABSOLUTE BI-POLAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR — Biomet Orthopedics, Inc.
- BIO-MODULAR — Biomet Orthopedics, Inc.
- BIO-MODULAR — Biomet Orthopedics, Inc.
- BIO-MODULAR / BI-POLAR SHOULDER — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
K872454 also covers:
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- Bio-Modular Shoulder System — Biomet Orthopedics, Inc.
K991807 also covers:
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
- Patient Matched Implants — Biomet Orthopedics, Inc.
K992119 also covers:
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
- BIO-MODULAR SHOULDER SYSTEM — Biomet Orthopedics, Inc.
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 8c7ccd5b-9481-4b90-90df-4017973dcd86 36 fields · synced May 30, 2026