Identity
- Trade Name
- Zimmer Patient Specific Instruments FDA UDI
- Generic Name
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
- Device Name
- NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA) CT FDA UDI
- Model / Reference
- 00-5970-000-16 FDA UDI
- Description
- NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA) CT FDA UDI
Identifiers
- Catalog Number
- 00-5970-000-16 FDA UDI
- Primary DI / UDI-DI
- E314005970000160 FDA UDI
- 510(k) Number
- K113829 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDIOOG FDA UDI
- GMDN Term
- Custom-made organ/bone anatomy model/surgical guide kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Zimmer Patient Specific Instruments by Materialise NV — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Materialise NV
Sources (1)
- FDA UDI 7223da6a-ee02-4c61-a8f0-78695f4f5620 36 fields · synced May 30, 2026