Identity
- Trade Name
- ZERO-P NATURAL FDA UDI
- Generic Name
- Manual orthopaedic bender, single-use FDA UDI
- Device Name
- ZERO-P NATURAL ASSEMBLY TOOL STERILE FDA UDI
- Model / Reference
- 03.617.014S FDA UDI
- Description
- ZERO-P NATURAL ASSEMBLY TOOL STERILE FDA UDI
Identifiers
- Catalog Number
- 03617014S FDA UDI
- Primary DI / UDI-DI
- 10705034816418 FDA UDI
- 510(k) Number
- K152239 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Manual orthopaedic bender, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
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
Category: Manual orthopaedic bender, single-use
Zero-P Natural by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual orthopaedic bender, single-use.
- Plate Benders (M) (2 Pieces) — FLOWER ORTHOPEDICS CORPORATION · Class I
- GEN2 — SURGIX MEDICAL LLC · Class I
- Plate Benders (S) (2 Pieces) — FLOWER ORTHOPEDICS CORPORATION · Class I
- EPS Plating System — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
Cleared under the same submission
K152239 also covers:
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
- Synthes
Sources (1)
- FDA UDI 17ec3c37-8bb2-4065-a6e5-3f2f2e31a1d4 36 fields · synced Jun 8, 2026