Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015176311

FEI Number

3015176311

Entity Name

PEAK IMPLEMENTS INC

City/State/Country

South River, NJ, US

Establishment Address

82 Willet Avenue, South River, NJ 08882, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Peak Implements Inc (Owner Number: 10059019)

Owner / Operator Contact Address

82 Willet Avenue, South River, NJ 08882, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT PUSHER, BAND, ORTHODONTIC HANDLE, INSTRUMENT, DENTAL FORCEPS, TOOTH EXTRACTOR, SURGICAL INSTRUMENT, CUTTING, ORTHOPEDIC SCALER, PERIODONTIC SCISSORS, COLLAR AND CROWN SCISSORS, ORTHOPEDIC, SURGICAL KNIFE, ORTHOPEDIC PROBE, PERIODONTIC MIRROR, MOUTH Lahey Hemostate Forceps 5 1/2" Curved Mosquito Artery Forceps Curved Ramsay Dissecting Forceps RONGEUR EXPLORER, OPERATIVE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-04-19
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2021-09-27
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2020-08-25
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2020-04-11
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2020-04-19
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2020-07-09
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2020-04-11
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2020-04-19
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	2020-04-19
EIX	Probe, Periodontic	Dental	Class 1	872.4565	2020-08-25
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2020-07-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2018-11-21
HTX	Rongeur	Orthopedic	Class 1	888.4540	2020-04-19
EKB	Explorer, Operative	Dental	Class 1	872.4565	2020-07-09

Official Correspondent

Muhammad Hussain

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Peak Implements 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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
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-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.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015176311. Last updated year: 2026. Please use registration number 3015176311 when referencing this establishment in official correspondence.