STERRAMED INC

FDA Device Registration & Listing · Weehawken, NJ, US · Registration 3042248499

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042248499
FEI Number
3042248499
Entity Name
STERRAMED INC
City/State/Country
Weehawken, NJ, US
Establishment Address
220 Highpoint Ave, Weehawken, NJ 07086, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Sterramed Inc (Owner Number: 10094296)
Owner / Operator Contact Address
220 Highpoint ave, Apt 1, Weehawken, NJ 07086, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

SterraMed Tube Introducer SterraMed Capener Gouge, 20 mm SterraMed Gouge Fiber Handle, 25 mm SterraMed Gouge Fiber Handle, 10 mm SterraMed Gouge Fiber Handle, 15 mm SterraMed Capener Gouge, 10 mm SterraMed Gouge Fiber Handle, 20 mm SterraMed Capener Gouge, 15 mm SterraMed Gouge Fiber Handle, 5 mm SterraMed Osteotome Fiber Handle, 20 mm SterraMed Osteotome Fiber Handle, 25 mm SterraMed Osteotome Fiber Handle, 10 mm SterraMed Osteotome Fiber Handle, 15 mm SterraMed Osteotome Fiber Handle, 5 mm SterraMed Compression Device SterraMed Reduction Clamp Serrated, 8 inch SterraMed Rochester Pean Kelly Clamp, Curved, Satin, 8" SterraMed Rochester Ochsner Clamp, Straight, Mirror, 6¼" SterraMed Reduction Clamp Serrated, 10 inch SterraMed Clamp, Schnidt, Tonsil, Closed Ring, Full Curve, 7½" SterraMed Reduction Clamp Pointed, 9 inch SterraMed Lowman’s Clamp, 8 inch SterraMed Reduction Clamp Pointed, 7 inch SterraMed Reduction Clamp Pointed, 8 inch SterraMed Reduction Clamp Pointed, 6 inch SterraMed Reduction Clamp Serrated, 9 inch SterraMed Clamp, Allis, Tissue, 6", 4x5 Teeth SterraMed Lowman’s Clamp, 4 inch SterraMed Reduction Clamp Serrated, 7 inch SterraMed Reduction Clamp Serrated, 6 inch SterraMed Rochester Ochsner Kocher Clamp, Straight, 7¼" SterraMed Reduction Clamp Pointed, 5 inch SterraMed Reduction Clamp Serrated, 5 inch SterraMed Reduction Clamp Pointed, 10 inch SterraMed Lowman’s Clamp, 6 inch SterraMed Electric Plaster Cutting Saw with Box SterraMed Awl, Straight and Curved, 4 mm SterraMed Awl for Humerus SterraMed Tudor Edward Rongeur, 45° SterraMed Leksell Rongeur SterraMed Sargent Rongeur, Straight SterraMed Ruskin Bone Rongeur, Double Action, Curved, 7 1/4", 5 mm Bite SterraMed Leksell Rongeur, Slightly Curved, 8 mm, 9 1/4" SterraMed Tudor Edward Rongeur, 90° SterraMed Kerrison Rongeur SterraMed Sargent Rongeur, Curved SterraMed Staude Moore Sweetheart Clamp, 6 1/2" SterraMed Depth Gauge for Humerus SterraMed Depth Gauge SterraMed Skin Hook and Nerve Hook SterraMed Dressing Forceps, Smooth, 10" SterraMed Lane’s Bone Holding Forceps, 12.5 inch SterraMed Self Centering Bone Holding Forceps, 12 inch SterraMed Lane’s Bone Holding Forceps with Ratchet, 12 inch SterraMed Adson Forceps, 1x2 Teeth, 4 3/4" SterraMed Lane’s Bone Holding Forceps with Ratchet, 8 inch SterraMed Self Centering Bone Holding Forceps, 4 inch SterraMed Burns Bone Holding Forceps, Large SterraMed Lane’s Bone Holding Forceps with Ratchet, 10 inch SterraMed Bonney Forceps, 2x3 Teeth, 6 3/4" SterraMed Tissue Forceps, 2x3 Teeth, 5 5/8" SterraMed Cushing Tissue Forceps, 1x2 Teeth, 7" SterraMed Self Centering Bone Holding Forceps, 10 inch SterraMed Self Centering Bone Holding Forceps, 6 inch SterraMed Heygroves Bone Holding Forceps, 12 inch SterraMed Burns Bone Holding Forceps, Medium SterraMed Heygroves Bone Holding Forceps, 8 inch SterraMed Burns Bone Holding Forceps, Small SterraMed Self Centering Bone Holding Forceps, 8 inch SterraMed Tissue Forceps, 1x2 Teeth, 10" SterraMed Heygroves Bone Holding Forceps, 10 inch SterraMed Extractor Bar SterraMed Hit Wire Cutter, 12 inch Long SterraMed Moon Cutter, 8 inch Long SterraMed Rod Cutter, 18 inch Extra Long SterraMed K Wire Cutter Cum Bender Cum Plier SterraMed Mayo Hegar Needle Holder, TC, 6" SterraMed Mayo Hegar Needle Holder, TC, 7" Head Extractor Rod with Hammer and Hooks SterraMed Slotted Hammer SterraMed Extractor Rod with Hammer SterraMed Self Retaining Retractor, 10 inch SterraMed Gelpi Retractor, 7 inch SterraMed Self Retaining Retractor, 8 inch SterraMed Self Retaining Retractor, 12 inch SterraMed Gelpi Retractor, 8 inch SterraMed Gelpi Retractor, 6 inch SterraMed Crile Clamp, Curved, Satin, 5 1/2" SterraMed Rochester Pean Kelly Clamp, Curved, Satin, 6 1/4" SterraMed DCS Triple Reamer SterraMed DHS Triple Reamer SterraMed Henning Plaster Spreader, Small SterraMed H D Plaster Cutting Saw SterraMed Henning Plaster Spreader, Large SterraMed Hollow Chisel SterraMed Chisel Fiber Handle, 20 mm SterraMed Chisel Fiber Handle, 25 mm SterraMed Chisel Fiber Handle, 15 mm SterraMed Chisel Fiber Handle, 10 mm SterraMed Chisel Fiber Handle, 5 mm SterraMed Surgical Ruler, 6 1/2" SterraMed AMP Rasp with Tomy Bar SterraMed Nail Impactor SterraMed DHS Screw Introducer and Impactor with Sleeve SterraMed Nylon Face Impactor SterraMed Tube Impactor, Nylon Face SterraMed Surgical Curette, Straight, Size 4, 8" SterraMed Surgical Curette, Angled, Size 2, 8" SterraMed Surgical Curette, Angled, Size 0, 8" SterraMed Surgical Curette, Straight, Size 2, 8" SterraMed Bruns Oval Curette, Straight, Size 0, 8" SterraMed Surgical Curette, Angled, Size 4, 8" SterraMed Protection Sleeve SterraMed Bone Nibbler Double Action, Straight, 7.5 inch SterraMed Disc Punch, Straight, 4 mm SterraMed Kerrison Punch, Upward, 45°, 2 mm, 3 mm, 4 mm SterraMed Patella Bone Holding S P with Guard, 10 inch SterraMed Humerus Trocar SterraMed Bone Cutter Double Action, Straight, 7.5 inch SterraMed Conic Bolt SterraMed Kerrison Punch, Upward, 90°, 2 mm, 3 mm, 4 mm SterraMed Patella Bone Holding D P Straight, 10 inch SterraMed Bone Nibbler Double Action, Curved, 7.5 inch SterraMed Lane Bone Lever, Plain SterraMed Hijack Punch, Upward, 45° and 90°, 2 mm, 3 mm, 4 mm SterraMed Disc Punch, Right Angle, 4 mm SterraMed Disc Punch, Left Angle, 2 mm SterraMed Bone Nibbler Double Action, Curved, 6 inch SterraMed Disc Punch, Upward, 4 mm SterraMed Interlocking Spanner SterraMed Bone Nibbler Double Action, Straight, 9 inch SterraMed Disc Punch, Right Angle, 2 mm SterraMed Drill Sleeve SterraMed Bone Cutter Double Action, Curved, 9 inch SterraMed Cervical Lamina Spreader with Gear SterraMed Coupling Handle SterraMed Final Punch SterraMed Disc Punch, Downward, 4 mm SterraMed Bone Cutter Double Action, Straight, 9 inch SterraMed Disc Punch, Straight, 2 mm SterraMed Disc Punch, Downward, 3 mm SterraMed Extraction Forcep SterraMed Murphy Skid SterraMed Disc Punch, Left Angle, 3 mm SterraMed Patella Bone Holding D P with Guard, 10 inch SterraMed Fixed Angle Guide, 130° and 135° SterraMed Bone Nibbler Double Action, Straight, 6 inch SterraMed T Handle with Chuck and Key SterraMed Kerrison Punch, Right, 45°, 2 mm, 3 mm, 4 mm SterraMed Disc Punch, Straight, 3 mm SterraMed Hijack Punch, Downward, 45° and 90°, 2 mm, 3 mm, 4 mm SterraMed Kerrison Punch, Downward, 90°, 2 mm, 3 mm, 4 mm SterraMed Patella Bone Holding D P Straight, 8 inch SterraMed Kerrison Punch, Downward, 45°, 2 mm, 3 mm, 4 mm SterraMed Patella Bone Holding D P with Guard, 8 inch SterraMed Adjustable Angle Guide SterraMed AMP Head Gauge, 37 to 53 mm SterraMed Disc Punch, Left Angle, 4 mm SterraMed Disc Punch, Upward, 3 mm SterraMed Bone Cutter Double Action, Straight, 6 inch SterraMed Lane Bone Lever, Serrated SterraMed Pointer SterraMed Disc Punch, Downward, 2 mm SterraMed Head Extractor, Judet SterraMed Disc Punch, Right Angle, 3 mm SterraMed Bone Cutter Double Action, Curved, 6 inch SterraMed Disc Punch, Upward, 2 mm SterraMed Cannulated Extraction and Impacting Hammer SterraMed Kerrison Punch, Up Bent, 90°, 2 mm, 3 mm, 4 mm SterraMed Tissue Protector SterraMed Bone Cutter Double Action, Curved, 7.5 inch SterraMed Patella Bone Holding S P, 6 inch SterraMed Bone Nibbler Double Action, Curved, 9 inch SterraMed Patella Bone Holding S P, 8 inch SterraMed Patella Bone Holding S P with Guard, 8 inch SterraMed Conical Bolt, Solid and Cannulated SterraMed Direct Measuring Device SterraMed Patella Bone Holding D P Curved, 10 inch SterraMed Bone Spike, A O Type, 8 mm SterraMed Cobb Gouge, Straight, 1/4" x 11" SterraMed DHS and DCS Tap with Sleeve SterraMed DCS Angle Guide, 95° SterraMed Patella Bone Holding S P, 10 inch SterraMed Bone Spike, A O Type, 6 mm SterraMed Femoral Awl, Straight SterraMed Patella Bone Holding D P Curved, 8 inch SterraMed F Tool SterraMed Kerrison Punch, Up Bent, 45°, 2 mm, 3 mm, 4 mm SterraMed Kerrison Punch, Left, 45°, 2 mm, 3 mm, 4 mm SterraMed Knife Handle No. 4 SterraMed Knife Handle No. 3 SterraMed Knife Handle No. 7

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BSR Stylet, Tracheal Tube Anesthesiology Class 1 868.5790 2025-12-17
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-12-17
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2025-12-17
HWN Instrument, Compression Orthopedic Class 1 888.4540 2025-12-17
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-11-24
LGH Instrument, Cast Removal, Ac-Powered Orthopedic Class 1 888.5960 2025-12-17
HWJ Awl Orthopedic Class 1 888.4540 2025-12-17
HTX Rongeur Orthopedic Class 1 888.4540 2025-11-25
HXD Clamp General, Plastic Surgery Class 1 878.4800 2025-11-25
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2025-12-17
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2025-12-17
HTD Forceps General, Plastic Surgery Class 1 878.4800 2025-11-25
HWB Extractor Orthopedic Class 1 888.4540 2025-12-17
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2025-12-17
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2025-11-24
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2025-12-17
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2025-12-17
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2025-11-25
HTO Reamer Orthopedic Class 1 888.4540 2025-12-17
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2025-12-17
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2025-12-17
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2025-11-25
HTR Rasp General, Plastic Surgery Class 1 878.4800 2025-12-17
HWA Impactor Orthopedic Class 1 888.4540 2025-12-17
HTF Curette General, Plastic Surgery Class 1 878.4800 2025-11-25
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2025-11-25
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2025-11-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sterramed Inc
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
K852723 The Huxley Instrument Corp. FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420 1985-07-15
K873512 Arthropedics, Inc. SERRATED GRASPING FORCEPS, RIGHT 1987-11-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2015 Biomet, Inc. 1
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0010-2008 N/A 1
EPIK KNEE SYSTEM Angled Insert Impactor RM/LL; Part #801-03-052 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042248499. Last updated year: 2026. Please use registration number 3042248499 when referencing this establishment in official correspondence.
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