Identity
- Trade Name
- Lineum® FDA UDI
- Generic Name
- Manual orthopaedic bender, reusable FDA UDI
- Model / Reference
- 14-525053 FDA UDI
Identifiers
- Catalog Number
- 14-525053 FDA UDI
- Primary DI / UDI-DI
- 00888480511557 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDIKWP FDA UDIMAX FDA UDIMQP FDA UDI
- GMDN Term
- Manual orthopaedic bender, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 FDA UDI888.3080 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Manual orthopaedic bender, reusable
Lineum® by Zimmer Biomet — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, reusable.
- MESA Small Stature Spinal System — K2M, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Kestrel® — Innovasis, Inc. · Class II
- Surgical Instrument — OSTEONIC CO., Ltd. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Dark Star Deformity — Republic Spine, LLC · Class II
- g Source — GSOURCE, LLC. · Class I
- CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
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
- Zimmer Biomet
Sources (1)
- FDA UDI 2a6cdb9a-e923-41f3-a07a-c6c8d5fb2645 34 fields · synced May 30, 2026