Identity
- Trade Name
- Memodyn staples FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Device Name
- BIPOD SHAPE MEMORY STAPLE FDA UDI
- Model / Reference
- CSU1610 FDA UDI
- Description
- BIPOD SHAPE MEMORY STAPLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615390002731 FDA UDI
- 510(k) Number
- K002695 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Memodyn staples by Groupe Lepine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone staple, non-adjustable.
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- Elite — Synthes · Class II
- MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
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- Speed Arc — Synthes · Class II
- JAWS Nitinol Staple System — Paragon 28 · Class II
Cleared under the same submission
K002695 also covers:
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
- Memodyn staples — GROUPE LEPINE
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
- Groupe Lepine
Sources (1)
- FDA UDI 9a278cf2-17ba-485f-b4b3-85891994264d 35 fields · synced Jun 6, 2026