Identity
- Trade Name
- CemSyntek Putty Convenience Kit 2.5cc FDA UDI
- Generic Name
- Orthopaedic cement spacer mould FDA UDI
- Device Name
- The CemSyntek Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads. FDA UDI
- Model / Reference
- ZS9213K-2 FDA UDI
- Description
- The CemSyntek Putty Convenience Kit (PCK) is a flexible polymer mat with cavities that allows the physician to mold bone putty into beads. FDA UDI
Identifiers
- Catalog Number
- ZS9213K-2 FDA UDI
- Primary DI / UDI-DI
- 00816125026128 FDA UDI
- 510(k) Number
- K022622 FDA UDI
- FDA Product Code
- MQV FDA UDI
- GMDN Term
- Orthopaedic cement spacer mould FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3045 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement spacer mould
CemSyntek Putty Convenience Kit 2.5cc by Berkeley Advanced Biomaterials — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement spacer mould.
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- CeMend 10-48 mold insert press — G21 SRL · Class II
- CEMENTON — Biomet Orthopedics, Inc. · Class II
- CeMend Shoulder Spacer Mold — G21 SRL · Class II
- STAGEONE SELECT — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K022622 also covers:
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
- Cem-Ostetic Putty — Berkeley Advanced Biomaterials
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
- Berkeley Advanced Biomaterials
Sources (1)
- FDA UDI b254c6c6-09f0-4157-8002-04b72b716c9e 35 fields · synced Jun 6, 2026