Identity
- Trade Name
- Wide Blade Super Slide Retractor Set FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- Wide Blade Super Slide Retractor Set, Consists of the Following: 1x 7329-410 - Wide Blade Retractor Frame 2x 7329-420 - Wide Blunt Blade 2 x 2 1/8", 2x 7329-422 - Wide Blunt Blade 2 x 3 1/8", 2x 7329-424 - Wide Blunt Blade 2 x 4 1/8", 2x 7329-430 - Wide Blade w/teeth 2 x 4 1/8", 2x 7329-432 - Wide Blade w/teeth 1 3/4 x 4 3/4", 2x 7329-434 - Wide Blade w/teeth 2 1/2 x 5 1/2", 1x 7329-440 - Sacral Blade, Left 2 x 3 1/2", 1x 7329-442 - Sacral Blade, Right 2 x 3 1/2", 1x 7329-444 - Sacral Blade, Left 2 3/4 x 2 1/2", 1x 7329-446 - Sacral Blade, Right 2 3/4 x 2 1/2", 1x 7329-448 - Sacral Blade, Left 3 x 3 ", 1x 7329-450 - Sacral Blade, Right 3 x 3 ", 2x 7329-460 - Unilateral Blade Head, 2x 7329-462 - Unilateral T-Blade 2 1/2", 1x 7329-470 - Wide Blade Retractor Case, FDA UDI
- Model / Reference
- 7329-400 FDA UDI
- Description
- Wide Blade Super Slide Retractor Set, Consists of the Following: 1x 7329-410 - Wide Blade Retractor Frame 2x 7329-420 - Wide Blunt Blade 2 x 2 1/8", 2x 7329-422 - Wide Blunt Blade 2 x 3 1/8", 2x 7329-424 - Wide Blunt Blade 2 x 4 1/8", 2x 7329-430 - Wide Blade w/teeth 2 x 4 1/8", 2x 7329-432 - Wide Blade w/teeth 1 3/4 x 4 3/4", 2x 7329-434 - Wide Blade w/teeth 2 1/2 x 5 1/2", 1x 7329-440 - Sacral Blade, Left 2 x 3 1/2", 1x 7329-442 - Sacral Blade, Right 2 x 3 1/2", 1x 7329-444 - Sacral Blade, Left 2 3/4 x 2 1/2", 1x 7329-446 - Sacral Blade, Right 2 3/4 x 2 1/2", 1x 7329-448 - Sacral Blade, Left 3 x 3 ", 1x 7329-450 - Sacral Blade, Right 3 x 3 ", 2x 7329-460 - Unilateral Blade Head, 2x 7329-462 - Unilateral T-Blade 2 1/2", 1x 7329-470 - Wide Blade Retractor Case, FDA UDI
Identifiers
- Catalog Number
- 7329-400 FDA UDI
- Primary DI / UDI-DI
- 10840199501066 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
Wide Blade Super Slide 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.
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- 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 Titanium 1" Wide Blade Radiolucent Retractor Set — 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.
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 80212a68-34f8-44da-8a31-a05ef8ba065f 37 fields · synced May 30, 2026