Identity
- Trade Name
- ToggleLoc with Ziploop FDA UDI
- Generic Name
- Ligament reconstruction instrument set, reusable FDA UDI
- Model / Reference
- 909854 FDA UDI
Identifiers
- Catalog Number
- 909854 FDA UDI
- Primary DI / UDI-DI
- 00880304470361 FDA UDI
- FDA Product Code
- MBI FDA UDIJDR FDA UDI
- GMDN Term
- Ligament reconstruction instrument set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
MR Conditional FDA UDI
Category: Ligament reconstruction instrument set, reusable
ToggleLoc with Ziploop by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083070 also covers:
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc With Ziploop — Biomet Orthopedics, Inc.
- ToggleLoc With Ziploop — Biomet Orthopedics, Inc.
- ToggleLoc With Ziploop — Biomet Orthopedics, Inc.
- ToggleLoc with Ziploop — Biomet Orthopedics, Inc.
K130033 also covers:
- TOGGLELOC XL WITH ZIPLOOP — Biomet Orthopedics, Inc.
- TOGGLELOC XL WITH ZIPLOOP INLINE — Biomet Orthopedics, Inc.
- TOGGLELOC™ WITH ZIPLOOP™ — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc With Ziploop — Biomet Orthopedics, Inc.
K973775 also covers:
- HARPOON — Biomet Orthopedics, Inc.
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc.
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc — Biomet Orthopedics, Inc.
- ToggleLoc With Ziploop — Biomet Orthopedics, Inc.
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 2cac9d23-eeaf-4f3a-a22b-f03e6b4d4809 36 fields · synced May 30, 2026