Identity
- Trade Name
- HIP OFFSET REUSABLE INSTRUMENT TRAY FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- HIP OFFSET REUSABLE INSTRUMENT TRAY FDA UDI
- Model / Reference
- 1080-123 FDA UDI
- Description
- HIP OFFSET REUSABLE INSTRUMENT TRAY FDA UDI
Identifiers
- Catalog Number
- 1080-123 FDA UDI
- Primary DI / UDI-DI
- 00810933031688 FDA UDI
- 510(k) Number
- K221104 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDIOQG FDA UDIMEH FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Joint prosthesis implantation kit, reusable
Hip Offset Reusable Instrument Tray by Conformis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Joint prosthesis implantation kit, reusable.
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- PROPHECY — MicroPort Orthopedics Inc. · Class II
- Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
- IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
- Evolution — MicroPort Orthopedics Inc. · Class II
- GUARDIAN® — MicroPort Orthopedics Inc. · Class I
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- PROPHECY — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K221104 also covers:
- ACTERA FEMORAL BROACH, SIZE 02 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 03 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 04 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 05 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 06 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 07 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 08 — Conformis, Inc.
- ACTERA FEMORAL BROACH, SIZE 09 — Conformis, Inc.
- ACTERA FEMORAL REUSABLE INSTRUMENT TRAY — Conformis, Inc.
- ACTERA FEMORAL STARTER BROACH — Conformis, Inc.
- ACTERA HIP REUSABLE TRIAL NECK, ACTERA, SIZE 04-05-06 HIGH OFFSET — Conformis, Inc.
- ACTERA HIP REUSABLE TRIAL NECK, ACTERA, SIZE 07-08-09 STANDARD — Conformis, 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
- Conformis, Inc.
Sources (1)
- FDA UDI 47519fe7-59f5-418b-af65-a7e918ed9a4a 36 fields · synced May 30, 2026