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Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- SUPER MAX ZIP ANCHOR Ø2,6mm 2 TAPES 1,3mm WHITE/BLUE AND WHITE/BLACK FDA UDI
- Model / Reference
- Super Max Zip Anchor FDA UDI
- Description
- SUPER MAX ZIP ANCHOR Ø2,6mm 2 TAPES 1,3mm WHITE/BLUE AND WHITE/BLACK FDA UDI
Identifiers
- Catalog Number
- 339-260-09 FDA UDI
- Primary DI / UDI-DI
- 07899258658971 FDA UDI
- 510(k) Number
- K223114 FDA UDI
- FDA Product Code
- MBI 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID
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
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- 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
Cleared under the same submission
K223114 also covers:
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors — GM DOS REIS INDUSTRIA E COMERCIO LTDA
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
- Gm Dos Reis Industria E Comercio Ltda
Sources (1)
- FDA UDI b49638f0-4fa8-4fc6-ad8d-75c59314a253 35 fields · synced Jun 8, 2026