Identity
- Trade Name
- THREADED ROD FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Model / Reference
- 10730-15 FDA UDI
Identifiers
- Catalog Number
- 1073015 FDA UDI
- Primary DI / UDI-DI
- 00887868005824 FDA UDI
- FDA Product Code
- HXK FDA UDIJDW FDA UDIKTT FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI888.3040 FDA UDI888.3030 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: External orthopaedic fixation system, single-use
Threaded Rod by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083789 also covers:
- 1/3 COMPOSITE RING, MEDIUM — Biomet Orthopedics, Inc.
- 2/3 COMPOSITE RING, MEDIUM — Biomet Orthopedics, Inc.
- 2/3 COMPOSITE RING, SMALL — Biomet Orthopedics, Inc.
- ACE-FISCHER ™CARBON FIBER COMPOSITE 1/2 RING, LARGE — Biomet Orthopedics, Inc.
- ACE-FISCHER ™CARBON FIBER COMPOSITE 1/2 RING, MEDIUM — Biomet Orthopedics, Inc.
- ACE-FISCHER ™CARBON FIBER COMPOSITE 1/2 RING, SMALL — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME CROSS BAR — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME POSTERIOR ANGLE — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL BOLT, LONG — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL LOCK HEX NUT — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL THREADED ROD — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL THREADED ROD — Biomet Orthopedics, Inc.
K112218 also covers:
- 1/3 COMPOSITE RING, MEDIUM — Biomet Orthopedics, Inc.
- 2/3 COMPOSITE RING, MEDIUM — Biomet Orthopedics, Inc.
- 2/3 COMPOSITE RING, SMALL — Biomet Orthopedics, Inc.
- ACE-FISCHER ™CARBON FIBER COMPOSITE 1/2 RING, LARGE — Biomet Orthopedics, Inc.
- ACE-FISCHER ™CARBON FIBER COMPOSITE 1/2 RING, MEDIUM — Biomet Orthopedics, Inc.
- ACE-FISCHER ™CARBON FIBER COMPOSITE 1/2 RING, SMALL — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME CROSS BAR — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME POSTERIOR ANGLE — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL BOLT, LONG — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL LOCK HEX NUT — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL THREADED ROD — Biomet Orthopedics, Inc.
- ACE-FISCHER ™STAINLESS STEEL THREADED ROD — Biomet Orthopedics, Inc.
K801594 also covers:
- ACE FISCHER™FOOT FRAME ELEVATOR — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME CROSS BAR — Biomet Orthopedics, Inc.
- ACE-FISCHER ™FOOT FRAME POSTERIOR ANGLE — Biomet Orthopedics, Inc.
- ACE-FISCHER ™LARGE FOOT FRAME — Biomet Orthopedics, Inc.
- ACE-FISCHER ™MEDIUM FOOT FRAME — Biomet Orthopedics, Inc.
- ACE-FISCHER ™MEDIUM FOOT RING — Biomet Orthopedics, Inc.
- ACE-FISCHER ™UNIVERSAL JOINT — Biomet Orthopedics, Inc.
- ACE-FISCHER®DISTRACTION WIRE — Biomet Orthopedics, Inc.
- ACE-FISCHER®OLIVE WIRE — Biomet Orthopedics, Inc.
- ACE-FISCHER®PIN HOLDER BOLT — Biomet Orthopedics, Inc.
- ADAPTOR ROD — Biomet Orthopedics, Inc.
- ADAPTOR ROD — 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI e2fd62b0-532a-440f-a483-1e2328e7cea2 36 fields · synced May 30, 2026