Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017155536

FEI Number

3017155536

Entity Name

SK PHARMA LOGISTICS GMBH

City/State/Country

Bielefeld North Rhine-Westphalia, DE

Establishment Address

Remusweg 8, Bielefeld North Rhine-Westphalia 33729, DE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SK Pharma Logistics GmbH (Owner Number: 10091163)

Owner / Operator Contact Address

Remusweg 8, Bielefeld, DE-NW 33729, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171582

PMA Number

N/A

All Registered Proprietary Names

Posterior retractor kit 60mm Posterior retractor kit 70mm Posterior retractor kit 50mm Posterior retractor kit 80mm Lateral retractor kit 120mm Lateral retractor kit 140mm Lateral retractor access kit Lateral retractor kit 180mm Lateral retractor kit 160mm Posterior retractor kit 40mm Posterior retractor access kit Cement Pusher Neo Pedicle Screw System Screw Guide Remover Cage Pusher Kit Cage straight curette kit Non-constraint torque limiter Marker Base (10x1) Removal Kit Single Use Pedicle marker (2x) Pedicle marker Revision Guide (10x1) Compressor Distractor Kit Revision Guide Scraper / distractor Cage Bent Curette Kit K-wire Kit Non-constraint torque limiter (10x) Ratchet T-Handle - 1/4", NS Persuader Cage holder Cage Instrument Kit T-Handle Kit Posterior instrument kit Cage puller Pedicle Screw Instrument Kit Steffee Neo Cage System NEO Pedicle Screw System Neo Cage System Screwdriver Adaptor - AO, NS Ratchet Handle - 1/4", NS Ratchet Screwdriver ¼, NS Neo Pedicle Screw System Screwdriver Handle, NS Set-screwdriver (10x1) Ratchet Handle - Hudson, NS Screwdriver Adaptor - 1/4", NS Screwdriver Converter - Hudson, NS Set screwdriver Screwdriver Adaptor - Hudson, NS Screwdriver Converter - AO, NS Screwdriver kit NEO Pedicle Screw System Sterile container Neo Pedicle Screw System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2024-07-24
KIH	Dispenser, Cement	Orthopedic	Class 1	888.4200	2024-07-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2025-01-16
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2025-01-16
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2025-01-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2024-07-24
HXB	Probe	Orthopedic	Class 1	888.4540	2024-07-23
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-07-15
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2024-07-15
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2024-07-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-15
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2024-07-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-07-15
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2024-07-24
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2024-07-15
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-15
PML	Bone Cement, Posterior Screw Augmentation	Orthopedic	Class 2	888.3027	2024-07-15
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-07-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2024-07-15

Official Correspondent

Lars Wiese

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

SK Pharma Logistics GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.

Similar Registrations

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3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017155536. Last updated year: 2026. Please use registration number 3017155536 when referencing this establishment in official correspondence.