Identity
- Trade Name
- Zimmer Natural Nail FDA UDI
- Generic Name
- Bone-nailing compression screw FDA UDI
- Model / Reference
- 82-0199-085-00 FDA UDI
Identifiers
- Catalog Number
- 82-0199-085-00 FDA UDI
- Primary DI / UDI-DI
- 00889024485426 FDA UDI
- 510(k) Number
- K130595 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone-nailing compression screw FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
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: Bone-nailing compression screw
Zimmer Natural Nail by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-nailing compression screw.
- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
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- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
- Compressor — Orthopedic Designs North America, Inc. · Class I
- Compression Tool with Tray — INTERVENTIONAL SPINE, INC · Class I
- Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
Cleared under the same submission
K130595 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
- Zimmer, Inc.
Sources (1)
- FDA UDI 720083e1-e988-4c30-9ae0-b27f962fe908 35 fields · synced May 30, 2026