Identity
- Trade Name
- Round Bone Impactor FDA UDI
- Generic Name
- External spinal fixation system FDA UDI
- Device Name
- Round Bone Impactor 7.5mm FDA UDI
- Model / Reference
- 7224-56 FDA UDI
- Description
- Round Bone Impactor 7.5mm FDA UDI
Identifiers
- Catalog Number
- 7224-56 FDA UDI
- Primary DI / UDI-DI
- 10840199500540 FDA UDI
- 510(k) Number
- K875290 FDA UDI
- FDA Product Code
- KWP FDA UDI
- GMDN Term
- External spinal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: External spinal fixation system
Round Bone Impactor by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External spinal fixation system.
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- King Cobra — EMINENT SPINE LLC · Class II
- 4CIS® INSTRUMENT SYSTEM — ALPHANOX CO., LTD. · Class I
- Fang Plate — EMINENT SPINE LLC · Class II
Cleared under the same submission
K875290 also covers:
- 30 deg Offset Impactor — Koros USA, Inc.
- 30 deg Offset Impactor — Koros USA, Inc.
- 30 deg Offset Impactor — Koros USA, Inc.
- 90 Degree Suction — Koros USA, Inc.
- 90 deg L Offset Impactor — Koros USA, Inc.
- 90 deg Suction Retractor — Koros USA, Inc.
- 90 deg T Impactor — Koros USA, Inc.
- 90 degree Suction — Koros USA, Inc.
- 90 degree Suction — Koros USA, Inc.
- Anterior Bone Impactor — Koros USA, Inc.
- Anterior Bone Impactor — Koros USA, Inc.
- Anterior Bone Impactor — Koros USA, 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
- Koros USA, Inc.
Sources (1)
- FDA UDI 2e36cab2-9e37-4b37-b298-da2fcfb409b9 38 fields · synced May 30, 2026