Identity
- Trade Name
- SPOTLIGHT FDA UDI
- Generic Name
- Surgical retractor/retraction system blade, reusable FDA UDI
- Device Name
- SPOTLIGHT PL BLADE LEFT 50mm FDA UDI
- Model / Reference
- 282951050 FDA UDI
- Description
- SPOTLIGHT PL BLADE LEFT 50mm FDA UDI
Identifiers
- Catalog Number
- 282951050 FDA UDI
- Primary DI / UDI-DI
- 10705034359014 FDA UDI
- 510(k) Number
- K113273 FDA UDI
- FDA Product Code
- FSQ FDA UDIGZT FDA UDI
- GMDN Term
- Surgical retractor/retraction system blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 FDA UDI882.4800 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
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
Category: Surgical retractor/retraction system blade, reusable
Spotlight by Depuy Spine, 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
- Specula Retractor Set — Koros USA, Inc. · Class I
Cleared under the same submission
K113273 also covers:
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, Inc.
- SPOTLIGHT — Depuy Spine, 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
- Depuy Spine, Inc.
Sources (1)
- FDA UDI b350f189-bf67-4e45-b4c1-f7461bf44dd4 36 fields · synced Jun 8, 2026