FDA.reportPublic FDA data

SMITH SAGGITAL SPLITTER-MOD

Primary DI
D9282000201SUL0
Brand
SMITH SAGGITAL SPLITTER-MOD
Company
W.H. Holden, Inc.
Model
20-0020-1-SUL
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9282000201SUL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
183854322
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D928105406HFDLC0STAHR TUNNEL RETRACTOR HF D/E DLC10-5406HFDLC2026-03-18
D928105535DLC0"""OH"" ZYGOMA RETRACTOR DLC"10-5535DLC2026-03-18
D9284004001CH0PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN40-0400-1CH2026-03-18
D9284004002CH0PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN40-0400-2CH2026-03-18
D928400400CH0PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE40-0400CH2026-03-18
D928400400HD0PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE40-0400HD2026-03-18
D928400400HF0PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE40-0400HF2026-03-18
D928400435RD0PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE40-0435RD2026-03-18
D9281051992HF0SINUS INSTRUMENT #2 HF D/E10-5199-2HF2026-02-19
D928400527H0POWERTOME S/E HF HANDLE40-0527H2026-01-27
D928106122R450SUCTION TIP #2-REGULAR - 45DEG RIGHT GRIND ANGLE10-6122-R452026-01-15
D9281059552HF570CURETTE SINUS LARGE PADDLE SHARP, SMALL PADDLE DULL, D/E HANDFORM HANDLE LONG10-5955-2HF572026-01-14
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLE40-0101CH2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLE40-0102CH2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLE40-0102HF2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLE40-0102R2026-01-14
D9284001040D928400104040-01042026-01-14
D928100600962DLC0EXTRACTION FORCEPS #962 UPPER DLC10-0600-962DLC2026-01-06
D9281009301850RONGEUR DOUBLE ACTION RUSKIN CURVED 18CM, 5MM10-0930-18-52026-01-06
D9281009302390RONGEUR DOUBLE ACTION RUSKIN CURVED 23CM, 6MM10-0930-23-62026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424503MillenniumAvalign Technologies, Inc.HTD2026-08-07
00841435122925TecometTECOMET INC.HTD2026-08-07
B382SD902508070Surgical DirectSurgical Direct, Inc.HTD2026-08-07
B382SD902509010Surgical DirectSurgical Direct, Inc.HTD2026-08-07
00190776422844MillenniumAvalign Technologies, Inc.HTD2026-08-03
B382SD4121490Surgical DirectSurgical Direct, Inc.HTD2026-08-03
00190776422349MillenniumAvalign Technologies, Inc.HTD2026-07-31
00810143904567SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906158SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906349SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906356SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906448SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931029SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931036SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931043SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931050SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931913SURGIPROSSurgipros, LLCHTD2026-07-31
00810212934907SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935133SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935638SURGIPROSSurgipros, LLCHTD2026-07-31
B382S028531010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S028531030Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S28531800Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S8541010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382SD1355500Surgical DirectSurgical Direct, Inc.HTD2026-07-31
00840277133724Innomed, Inc.INNOMED, INC.HTD2026-07-29
B382SD92022614E0Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9203561000Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9206011020Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B3825SD918621130Surgical DirectSurgical Direct, Inc.HTD2026-07-28