Identity
- Trade Name
- Symmetry Selverstone FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- Symmetry® Rongeur; Selverstone IVD; 2 mm x 3 mm Cup; 6 in FDA UDI
- Model / Reference
- 57-1255 FDA UDI
- Description
- Symmetry® Rongeur; Selverstone IVD; 2 mm x 3 mm Cup; 6 in FDA UDI
Identifiers
- Catalog Number
- 57-1255 FDA UDI
- Primary DI / UDI-DI
- 00887482094341 FDA UDI
- 510(k) Number
- K081651 FDA UDI
- FDA Product Code
- HAE FDA UDI
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4840 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDIWidth — 2 Millimeter FDA UDIDepth — 3 Millimeter FDA UDI
Category: Spinal rongeur
Symmetry Selverstone by Symmetry Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal rongeur.
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Cleared under the same submission
K081651 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Symmetry Surgical Inc.
Sources (1)
- FDA UDI 54231a27-de42-4ec0-a285-eb95b6e1deaa 37 fields · synced Jun 8, 2026