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Super Slide Titanium 1" Wide Blade Radiolucent Retractor Set
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Super Slide Titanium 1" Wide Blade Radiolucent Retractor Set FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- 1” Wide Blade Titanium Super-Slide Radiolucent Retractor Set, Consists of the Following: 1x 7329-110 - Stainless Steel Wide Blade Retractor Frame 4x 7329-320 - Titanium 1” Wide Blade 1" x 2" 4x 7329-330 - Titanium 1” Wide Blade 1" x 3" 4x 7329-340 - Titanium 1” Wide Blade 1" x 4" 4x 7329-347 - Titanium 1” Wide Blade 1" x 4-3/4" 2x 7329-460 - Unilateral Blade Heads 2x 7329-462 - Unilateral T-Blades 2-1/2" 1x 7329-370 - Titanium Wide Blade Retractor Case FDA UDI
- Model / Reference
- 7329-200 FDA UDI
- Description
- 1” Wide Blade Titanium Super-Slide Radiolucent Retractor Set, Consists of the Following: 1x 7329-110 - Stainless Steel Wide Blade Retractor Frame 4x 7329-320 - Titanium 1” Wide Blade 1" x 2" 4x 7329-330 - Titanium 1” Wide Blade 1" x 3" 4x 7329-340 - Titanium 1” Wide Blade 1" x 4" 4x 7329-347 - Titanium 1” Wide Blade 1" x 4-3/4" 2x 7329-460 - Unilateral Blade Heads 2x 7329-462 - Unilateral T-Blades 2-1/2" 1x 7329-370 - Titanium Wide Blade Retractor Case FDA UDI
Identifiers
- Catalog Number
- 7329-200 FDA UDI
- Primary DI / UDI-DI
- 10840199500861 FDA UDI
- 510(k) Number
- K881160 FDA UDI
- FDA Product Code
- GZT FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, 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: Surgical retractor/retraction system blade, reusable
Super Slide Titanium 1" Wide Blade Radiolucent Retractor Set by Koros USA, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retractor/retraction system blade, reusable.
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Medfix — Medfix International, LLC · Class I
- DELACROIX-CHEVALIER — LANDANGER · Class I
- MSI — Modern Surgical Instruments LLC · Class I
- TSI — TEDAN SURGICAL INNOVATIONS, L.L.C. · Class I
- Life Instruments — Life Instrument Corporation · Class I
- Medfix — Medfix International, LLC · Class I
- CANYON™ Retractor Systems — K2M, INC. · Class I
Cleared under the same submission
K881160 also covers:
- All Titanium Super Slide III Self Retaining Retractor, Extended Set — Koros USA, Inc.
- Clear View S-Slide II Instrument Case — Koros USA, Inc.
- Clearview Super Slide Lumbar Retractor, Basic Set — Koros USA, Inc.
- Double Crank Spinal Blade — Koros USA, Inc.
- Double Crank Spinal Retractor Frame, McElroy Stainless Steel — Koros USA, Inc.
- S-Slide All Titanium Wide Blade Retractor Frame — Koros USA, Inc.
- Super Slide II Self Retaining Retractor, Extended Set — Koros USA, Inc.
- Super Slide III Ti Retractor Frame — Koros USA, Inc.
- Super-Slide 1" Wide Blade — Koros USA, Inc.
- Super-Slide 1" Wide Blade — Koros USA, Inc.
- Super-Slide 1" Wide Titanium Blade — Koros USA, Inc.
- Super-Slide 1" Wide Titanium Blade — 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 |
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Manufacturer
- Manufacturer
- Koros USA, Inc.
Sources (1)
- FDA UDI ec1aae03-f0af-4c07-b47a-46f16f53c663 37 fields · synced May 30, 2026