Identity
- Trade Name
- Symmetry ® EUDAMEDSymmetry Kerrison FDA UDI
- Generic Name
- Orthopaedic joint/limb rongeur FDA UDI
- Device Name
- Rongeurs EUDAMEDSymmetry® Kerrison Rongeur, Spurling, 40° Up, 5.0 mm Jaw, 15.0 mm Open, 7 in FDA UDI
- Model / Reference
- 57-0555 EUDAMEDFDA UDI
- Description
- Symmetry® Kerrison Rongeur, Spurling, 40° Up, 5.0 mm Jaw, 15.0 mm Open, 7 in FDA UDI
Identifiers
- Catalog Number
- 57-0555 FDA UDI
- Primary DI / UDI-DI
- 00887482092224 EUDAMEDFDA UDI
- Basic UDI-DI
- 08401132RongeurLP EUDAMED
- 510(k) Number
- K081651 FDA UDI
- FDA Product Code
- HAE FDA UDI
- EMDN Code
- L0399 GENERAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic joint/limb rongeur FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4840 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 5 Millimeter FDA UDIAngle — 40 degree FDA UDILength — 7 Inch FDA UDI
Category: Orthopaedic joint/limb rongeur
Symmetry Kerrison by Symmetry Surgical Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic joint/limb 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Symmetry Surgical Inc.
Sources (2)
- FDA UDI d6e8a3a3-f01d-48fa-9572-f196a2d93600 37 fields · synced Aug 1, 2026
- EUDAMED 03c988b8-7a4f-41dc-b9b3-e9420f4e1628 61 fields · synced Aug 1, 2026