Identity
- Trade Name
- REACH MODULAR HIP SYSTEM FDA UDI
- Generic Name
- Uncoated knee femur prosthesis, metallic FDA UDI
- Model / Reference
- 21-108399 FDA UDI
Identifiers
- Catalog Number
- 21-108399 FDA UDI
- Primary DI / UDI-DI
- 00880304282124 FDA UDI
- FDA Product Code
- LPH FDA UDIMEH FDA UDI
- GMDN Term
- Uncoated knee femur prosthesis, metallic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Uncoated knee femur prosthesis, metallic
Reach Modular Hip System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uncoated knee femur prosthesis, metallic.
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- LEGION — Smith & Nephew, Inc. · Class II
- LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II
- GMK Sphere Revision System — Medacta International · Class II
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- Balance Knee Revision System — ORTHO DEVELOPMENT CORP. · Class II
- LinkSymphoKnee — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K022463 also covers:
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
- REACH MODULAR HIP SYSTEM — Biomet Orthopedics, Inc.
K030055 also covers:
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BALANCE HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc.
- BI-METRIC REVISION HIP 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 225e7a4c-f712-4db2-b80a-eb67d5db7a62 36 fields · synced Jun 8, 2026