Identity
- Trade Name
- Balanced Knee Revision System FDA UDI
- Generic Name
- Sleeve femoral/tibial extension, coated FDA UDI
- Device Name
- Femoral Sleeve 34mm M-L 22mm A/P FDA UDI
- Model / Reference
- 561-5034 FDA UDI
- Description
- Femoral Sleeve 34mm M-L 22mm A/P FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409037872 FDA UDI
- 510(k) Number
- K181569 FDA UDI
- FDA Product Code
- JWH FDA UDIMBH FDA UDI
- GMDN Term
- Sleeve femoral/tibial extension, coated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3560 FDA UDI888.3565 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
Dimensions & Sizes
- Size
- Length — 34 Millimeter FDA UDIHeight — 59.6 Millimeter FDA UDIWidth — 22 Millimeter FDA UDI
Category: Sleeve femoral/tibial extension, coated
Balanced Knee Revision System by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sleeve femoral/tibial extension, coated.
- S-ROM ZTT — DEPUY ORTHOPAEDICS, INC. · Class III
- Coated Revision Stem — Signal Medical Corp. · Class II
- AMF TT CONES — Limacorporate · Class II
- AMF TT CONES — Limacorporate · Class II
- AMF TT CONES — Limacorporate · Class II
- Optetrak Logic — Exactech, Inc. · Class II
- Coated Revision Stem — Signal Medical Corp. · Class II
- S-ROM ZTT — DEPUY ORTHOPAEDICS, INC. · Class III
Cleared under the same submission
K181569 also covers:
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
- Balanced Knee Revision System — ORTHO DEVELOPMENT CORP.
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
- Ortho Development Corp.
Sources (1)
- FDA UDI a74e3cda-8075-4312-b63f-5b96bce128db 36 fields · synced Jun 8, 2026