Identity
- Trade Name
- Sirus FDA UDI
- Generic Name
- Hip prosthesis socket pusher FDA UDI
- Model / Reference
- SSI004280 FDA UDI
Identifiers
- Catalog Number
- SSI004280 FDA UDI
- Primary DI / UDI-DI
- 00887868248702 FDA UDI
- 510(k) Number
- K130610 FDA UDI
- FDA Product Code
- PBI FDA UDIOQI FDA UDIOQG FDA UDIMEH FDA UDILZY FDA UDILZO FDA UDILPH FDA UDIKWY FDA UDIKWL FDA UDIJDI FDA UDIJDG FDA UDI
- GMDN Term
- Hip prosthesis socket pusher FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 FDA UDI888.3353 FDA UDI888.3358 FDA UDI888.3360 FDA UDI888.3390 FDA UDI888.3350 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: Hip prosthesis socket pusher
Sirus by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hip prosthesis socket pusher.
- MobiliT Cup — CORIN LTD · Class II
- LINK Instruments - Impactors, extractors and insertion — WALDEMAR LINK GmbH & Co. KG · Class I
- Trinity Acetabular Hip System — CORIN LTD · Class II
- LINK Instruments - Impactors, extractors and insertion — WALDEMAR LINK GmbH & Co. KG · Class I
- LINK Instruments - Impactors, extractors and insertion — WALDEMAR LINK GmbH & Co. KG · Class I
- LINK Instruments - Trial implants and size gauges — WALDEMAR LINK GmbH & Co. KG · Class I
- LINK Instruments - Impactors, extractors and insertion — WALDEMAR LINK GmbH & Co. KG · Class I
- LINK Instruments - Impactors, extractors and insertion — WALDEMAR LINK GmbH & Co. KG · Class I
Cleared under the same submission
K130610 also covers:
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — Biomet Orthopedics, Inc.
- SIRIUS — 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 4d93ae5d-0e5b-4025-b6bb-db8b1ea27534 35 fields · synced Jun 6, 2026