Identity
- Trade Name
- Black Belt Extended Retractor System All Titanium FDA UDI
- Generic Name
- Self-retaining surgical retractor, reusable FDA UDI
- Device Name
- Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x 7320-20M - Retractor Frame Left, 1x 7320-30M - Retractor Frame Offset, 2x 7320-40M - Blade Inserting Clamps, 2x 7322-34M - Pronged Ti Blades, 2x 7322-40M - Pronged Ti Blades, 2x 7322-45M - Pronged Ti Blades, 2x 7322-50M - Pronged Ti Blades, 2x 7322-55M - Pronged Ti Blades, 2x 7322-60M - Pronged Ti Blades, 2x 7322-70M - Pronged Ti Blades, 2x 7324-34M - Blunt Ti Blades, 2x 7324-40M - Blunt Ti Blades, 2x 7324-45M - Blunt Ti Blades, 2x 7324-50M - Blunt Ti Blades, 2x 7324-55M - Blunt Ti Blades, 2x 7324-60M - Blunt Ti Blades, 2x 7324-70M - Blunt Ti Blades, 4x 7326-40M - Two-Level Ti Blades Pronged, 4x 7326-47M - Two-Level Ti Blades Pronged, 4x 7326-55M - Two-Level Ti Blades Pronged, 2x 7328-40M - Two-Level Ti Blades Blunt, 2x 7328-47M - Two-Level Ti Blades Blunt, 2x 7328-55M - Two-Level Ti Blades Blunt, 1x 7320-90M - Sterilizing Instrument Case with silicone inserts, 1x 7321-10M - Microdiscectomy Adaptor, 1x 7321-20M - Spike Blade 70 mm, 1x 7321-30M - T-Shape Blade 70mm, 1x 7321-40M - Inner Spine Ligament Blade 70mm, 1x 7322-85M - Pronged Ti Blade 22x85mm, 1x 7322-75M - 15cm long Retractor Rack. FDA UDI
- Model / Reference
- 7320-05M FDA UDI
- Description
- Black Belt Extended Retractor System All Titanium Consists of the following: 1x 7320-22M - Korpectomy Retractor Frame Right, 1x 7320-20M - Retractor Frame Left, 1x 7320-30M - Retractor Frame Offset, 2x 7320-40M - Blade Inserting Clamps, 2x 7322-34M - Pronged Ti Blades, 2x 7322-40M - Pronged Ti Blades, 2x 7322-45M - Pronged Ti Blades, 2x 7322-50M - Pronged Ti Blades, 2x 7322-55M - Pronged Ti Blades, 2x 7322-60M - Pronged Ti Blades, 2x 7322-70M - Pronged Ti Blades, 2x 7324-34M - Blunt Ti Blades, 2x 7324-40M - Blunt Ti Blades, 2x 7324-45M - Blunt Ti Blades, 2x 7324-50M - Blunt Ti Blades, 2x 7324-55M - Blunt Ti Blades, 2x 7324-60M - Blunt Ti Blades, 2x 7324-70M - Blunt Ti Blades, 4x 7326-40M - Two-Level Ti Blades Pronged, 4x 7326-47M - Two-Level Ti Blades Pronged, 4x 7326-55M - Two-Level Ti Blades Pronged, 2x 7328-40M - Two-Level Ti Blades Blunt, 2x 7328-47M - Two-Level Ti Blades Blunt, 2x 7328-55M - Two-Level Ti Blades Blunt, 1x 7320-90M - Sterilizing Instrument Case with silicone inserts, 1x 7321-10M - Microdiscectomy Adaptor, 1x 7321-20M - Spike Blade 70 mm, 1x 7321-30M - T-Shape Blade 70mm, 1x 7321-40M - Inner Spine Ligament Blade 70mm, 1x 7322-85M - Pronged Ti Blade 22x85mm, 1x 7322-75M - 15cm long Retractor Rack. FDA UDI
Identifiers
- Catalog Number
- 7320-05M FDA UDI
- Primary DI / UDI-DI
- 10840199501844 FDA UDI
- 510(k) Number
- K935529 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Self-retaining surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Self-retaining surgical retractor, reusable
Black Belt Extended Retractor System All Titanium by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, reusable.
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- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
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- Life Instruments — Life Instrument Corporation · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, Inc. · Class I
Cleared under the same submission
K935529 also covers:
- Bea Style Blunt Ti Blade — Koros USA, Inc.
- Bea Style Pronged Ti Blade — Koros USA, Inc.
- Black Belt Blunt Blade — Koros USA, Inc.
- Black Belt Blunt Blade — Koros USA, Inc.
- Black Belt Blunt Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Blunt Ti Blade — Koros USA, Inc.
- Black Belt Cervical Retractor 70mm Spike Blade — Koros USA, Inc.
- Black Belt Cervical Retractor Basic Set All Titanium — Koros USA, 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
- Koros USA, Inc.
Sources (1)
- FDA UDI 9328da5e-06ec-4fb5-af27-b9346bb439c6 37 fields · synced May 31, 2026