Identity
- Trade Name
- BRISTOW LATARJET FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- Bristow - Latarjet Instability Shoulder Screw 36mm Titanium Screw & Top Hat; Quanitity: (1) Screw; (1) Top Hat FDA UDI
- Model / Reference
- 285112 FDA UDI
- Description
- Bristow - Latarjet Instability Shoulder Screw 36mm Titanium Screw & Top Hat; Quanitity: (1) Screw; (1) Top Hat FDA UDI
Identifiers
- Catalog Number
- 285112 FDA UDI
- Primary DI / UDI-DI
- 10886705020638 FDA UDI
- 510(k) Number
- K110763 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Bristow Latarjet by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
- OrthoButton AL — RIVERPOINT MEDICAL LLC · Class II
Cleared under the same submission
K110763 also covers:
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, Inc.
- BRISTOW LATARJET — DePuy Mitek, 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 |
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Manufacturer
- Manufacturer
- DePuy Mitek, Inc.
Sources (1)
- FDA UDI d8099474-6820-4085-a572-e2e5a4b0654c 37 fields · synced May 31, 2026