Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1219518

FEI Number

1219518

Entity Name

HOLMED LLC

City/State/Country

Attleboro, MA, US

Establishment Address

48 Frank Mossberg Drive., Building #1, Attleboro, MA 02703, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

NN Inc Power Solutions (Owner Number: 1219518)

Owner / Operator Contact Address

4070 East Paris., Kentwood, MI 49512, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PUSHER, SOCKET GAUGE, DEPTH HEAD, SURGICAL, HAMMER Intervertebral fusion device with integrated fixation, cervical DRIVER, PROSTHESIS CHISEL, NASAL Dermatome HANDPIECE (BRACE), DRILL BI-POLAR PROV HANDLE OSTEOTOME, MANUAL CURETTE, SURGICAL, DENTAL FORCEPS, GENERAL & PLASTIC SURGERY Guide, surgical, instrument PUNCH, SKULL TAP, BONE EXTRACTOR CURETTE, SURGICAL, GENERAL USE PASSER CHISEL (OSTEOTOME) CUTTER, WIRE Retractor, ophthalmic FORCEPS Hook, ophthalmic OSTEOTOME ELEVATOR, ENT TAMP WRENCH Spinal vertebral body replacement device PROBE CLAMP SCISSORS, ORTHOPEDIC, SURGICAL DEVICE, PROSTHESIS ALIGNMENT TRAY, SURGICAL, INSTRUMENT Pliers, operative REAMER RASP, SURGICAL, GENERAL & PLASTIC SURGERY Orthopedic manual surgical instrument BENDER DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY CURETTE CARRIER, LIGATURE ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY BURR, ORTHOPEDIC CHISEL, SURGICAL, MANUAL CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY TEMPLATE IMPACTOR RACK, CLIP CHISEL, OSTEOTOME, SURGICAL MALLET, SURGICAL, GENERAL & PLASTIC SURGERY INSTRUMENT, COMPRESSION GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY Dilator, lachrymal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	1979-10-31
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	1979-10-31
GFB	Head, Surgical, Hammer	General, Plastic Surgery	Class 1	878.4820	1979-10-31
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2015-02-13
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	1979-10-31
KAN	Chisel, Nasal	General, Plastic Surgery	Class 1	878.4800	1979-10-31
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	1979-10-31
HBD	Handpiece (Brace), Drill	Neurology	Class 1	882.4325	1979-10-31
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2023-05-07
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	1979-10-31
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	1979-10-31
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1993-12-01
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1979-10-31
GXJ	Punch, Skull	Neurology	Class 1	882.4750	1979-10-31
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	1979-10-31
HWB	Extractor	Orthopedic	Class 1	888.4540	1979-10-31
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1979-10-31
HWQ	Passer	Orthopedic	Class 1	888.4540	1979-10-31
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	1979-10-31
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	1979-10-31
HNI	Retractor, Ophthalmic	Ophthalmic	Class 1	886.4350	1979-10-31
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	1983-11-03
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	1979-10-31
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1979-10-31
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	1979-10-31
HXG	Tamp	Orthopedic	Class 1	888.4540	1979-10-31
HXC	Wrench	Orthopedic	Class 1	888.4540	1979-10-31
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2015-04-28
HXB	Probe	Orthopedic	Class 1	888.4540	2015-04-27
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1979-10-31
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	1993-12-01
IQO	Device, Prosthesis Alignment	Physical Medicine	Class 1	890.3025	1979-10-31
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1986-02-28
EJY	Pliers, Operative	Dental	Class 1	872.4565	2001-10-04
HTO	Reamer	Orthopedic	Class 1	888.4540	1979-10-31
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-10-31
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-07-13
HXW	Bender	Orthopedic	Class 1	888.4540	2015-04-27
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-10-31
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1979-10-31
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	1979-10-31
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-10-31
HTT	Burr, Orthopedic	Orthopedic	Class 1	888.4540	1979-10-31
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1979-10-31
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	1979-10-31
HWT	Template	Orthopedic	Class 1	888.4800	1979-10-31
HWA	Impactor	Orthopedic	Class 1	888.4540	1979-10-31
HBR	Rack, Clip	Neurology	Class 1	882.4215	1979-10-31
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	1979-10-31
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-10-31
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	1979-10-31
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1979-10-31
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	1979-10-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NN Inc Power Solutions

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
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18
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-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1219518. Last updated year: 2026. Please use registration number 1219518 when referencing this establishment in official correspondence.