Identity
- Trade Name
- 3DP Lumbar Interbody System FDA UDI
- Generic Name
- Spinal rongeur FDA UDI
- Device Name
- 12in 2mm Pituitary Rongeur FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 12in 2mm Pituitary Rongeur FDA UDI
Identifiers
- Catalog Number
- GP532-2 FDA UDI
- Primary DI / UDI-DI
- M719GP53220 FDA UDI
- 510(k) Number
- K182987 FDA UDI
- FDA Product Code
- HTX FDA UDI
- GMDN Term
- Spinal rongeur FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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: Spinal rongeur
3DP Lumbar Interbody System by Genesys Orthopedics Systems LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal rongeur.
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- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- V. Mueller — STERIS CORPORATION · Class II
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Cleared under the same submission
K182987 also covers:
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
- 3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC
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 I | Pending data |
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Manufacturer
- Manufacturer
- Genesys Orthopedics Systems LLC
Sources (1)
- FDA UDI 56a0f7e8-4b0f-4f27-9b25-413dbeea8f8c 36 fields · synced Jun 1, 2026