FDA Device Registration & Listing · Wellendingen Baden-Wurttemberg, DE · Registration 3010235355
Normalized identity and public registration information from FDA records.
No proprietary names listed under this establishment.
| Product Code | Device Name | Medical Specialty | Device Class | Regulation Number | Created Date |
|---|---|---|---|---|---|
| HTF | Curette | General, Plastic Surgery | Class 1 | 878.4800 | 2015-12-01 |
| HTX | Rongeur | Orthopedic | Class 1 | 888.4540 | 2014-10-24 |
| HTR | Rasp | General, Plastic Surgery | Class 1 | 878.4800 | 2016-11-07 |
| LRP | Tray, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2018-05-30 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2021-05-19 |
| GEN | Forceps, General & Plastic Surgery | General, Plastic Surgery | Class 1 | 878.4800 | 2013-05-27 |
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | Class 1 | 878.4800 | 2023-06-07 |
| HXW | Bender | Orthopedic | Class 1 | 888.4540 | 2020-05-12 |
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2019-09-12 |
| HWN | Instrument, Compression | Orthopedic | Class 1 | 888.4540 | 2020-05-12 |
| HTJ | Gauge, Depth | Orthopedic | Class 1 | 888.4300 | 2014-10-24 |
| FZO | Chisel, Surgical, Manual | General, Plastic Surgery | Class 1 | 878.4800 | 2014-10-24 |
| HWT | Template | Orthopedic | Class 1 | 888.4800 | 2018-04-18 |
| GAD | Retractor | General, Plastic Surgery | Class 1 | 878.4800 | 2015-12-01 |
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | Class 1 | 870.4500 | 2013-05-27 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2021-03-31 |
| HTE | Elevator | General, Plastic Surgery | Class 1 | 878.4800 | 2016-06-23 |
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | Class 1 | 888.4540 | 2020-04-01 |
| HTD | Forceps | General, Plastic Surgery | Class 1 | 878.4800 | 2014-10-24 |
| HXX | Screwdriver | Orthopedic | Class 1 | 888.4540 | 2018-11-13 |
| DXC | Clamp, Vascular | Cardiovascular | Class 2 | 870.4450 | 2020-03-06 |
| FZY | Hammer, Surgical | General, Plastic Surgery | Class 1 | 878.4800 | 2015-03-11 |
| LXI | Guide, Drill, Ligament | General, Plastic Surgery | Class 1 | 878.4820 | 2019-05-27 |
| HXP | Instrument, Bending Or Contouring | Orthopedic | Class 1 | 888.4540 | 2025-12-18 |
| HXK | Holder, Needle; Orthopedic | Orthopedic | Class 1 | 888.4540 | 2019-05-27 |
| 510(k) Number | Applicant | Device Name | Decision Date |
|---|---|---|---|
| K881095 | CooperVision, Inc. | KOI(TM) INSTRUMENT TRAYS | 1988-04-06 |
| K851170 | The Huxley Instrument Corp. | DISSECTING TWEEZER #283-72PCS. SS 410 | 1985-04-25 |
| K821248 | Conphar, Inc. | ROCHESTER PEAN FORCEPS | 1982-05-28 |
| 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 |
| Recall ID | Recalling Firm | Recall Class | Product Description |
|---|---|---|---|
| Z-0036-2010 | Alphatec Spine, Inc. | 1 | ROC Lumbar bolt caddy, Part Number: 81997-01-05.
Sterilization container for ROC bolts/screws. Product is used to contain spinal implants. |
| Z-0040-2018 | Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446 | 1 | Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System
The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis. |
| Z-0031-2014 | Aesculap, Inc. | 1 | UNITRAC Pneumatic Retraction Arm.
A support arm used to hold surgical instruments during surgical procedures. |
| Z-0008-04 | Rultract Inc | 1 | Rultract Surgical Retractor, 4100 Series, all system configurations, reusable. |
| Z-0009-2007 | Smith & Nephew Inc | 1 | Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817. |
| Registration Number | Establishment Name | Location |
|---|---|---|
| 3011499367 | HAZEL ENTERPRISES | Sialkot Punjab, PK |
| 3006410968 | ROBINSON HEALTHCARE LIMITED | Worksop Nottinghamshire, GB |
| 3004608878 | INTEGRA LIFESCIENCES CORPORATION | CINCINNATI, OH, US |
| 3003956316 | COMMIC SURGICO | SIALKOT Punjab, PK |
| 3007366790 | Smith & Nephew, Inc. | Memphis, TN, US |
3010235355 when referencing this establishment in official correspondence.