Identity
- Trade Name
- BMP CABLE SYSTEM FDA UDI
- Generic Name
- Orthopaedic bone wire FDA UDI
- Model / Reference
- 350800 FDA UDI
Identifiers
- Catalog Number
- 350800 FDA UDI
- Primary DI / UDI-DI
- 00880304004054 FDA UDI
- 510(k) Number
- K982545 FDA UDI
- FDA Product Code
- HRS FDA UDIJDQ FDA UDI
- GMDN Term
- Orthopaedic bone wire FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3010 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: Orthopaedic bone wire
Bmp Cable System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone wire.
- mahe medical GmbH — mahe medical gmbh · Class II
- SALVATION™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- mahe medical GmbH — mahe medical gmbh · Class II
- OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- gSource — GSOURCE, LLC. · Class II
- APTUS — Medartis Inc. · Class II
- gSource — GSOURCE, LLC. · Class II
Cleared under the same submission
K982545 also covers:
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE SYSTEM — Biomet Orthopedics, Inc.
- BMP CABLE 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 a14b3665-4aa9-403a-868f-c6d66e34f9d0 36 fields · synced May 31, 2026